Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT03760458
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2018-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106538', 'term': 'abacavir'}, {'id': 'C000631408', 'term': 'abacavir, dolutegravir, and lamivudine drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IMPAACT.ctgov@fstrf.org', 'phone': '(919) 405-1429', 'title': 'IMPAACT Clinicaltrials.gov Coordinator', 'organization': 'Family Health International (FHI 360)'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study entry to study completion (at Week 48 or 60) or premature study discontinuation', 'description': 'All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs\n\nThe definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study', 'eventGroups': [{'id': 'EG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Secondary thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Conjunctival pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 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'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 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'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tonsillar exudate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tonsillar inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Perioral dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Skin plaque', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Abacavir (ABC)', 'categories': [{'measurements': [{'value': '17.7', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '50.6', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '40.3', 'groupId': 'OG002'}, {'value': '17.4', 'spread': '19.4', 'groupId': 'OG003'}, {'value': '25.7', 'spread': '14.6', 'groupId': 'OG004'}]}]}, {'title': 'Dolutegravir (DTG)', 'categories': [{'measurements': [{'value': '75.9', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '91.0', 'spread': '36.5', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '84.4', 'spread': '26.3', 'groupId': 'OG003'}, {'value': '71.8', 'spread': '13.9', 'groupId': 'OG004'}]}]}, {'title': 'Lamivudine (3TC)', 'categories': [{'measurements': [{'value': '10.7', 'spread': '46.0', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '23.9', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '15.6', 'groupId': 'OG002'}, {'value': '14.5', 'spread': '16.6', 'groupId': 'OG003'}, {'value': '21.7', 'spread': '26.2', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.', 'description': 'Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug\\*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '7.30', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '8.36', 'spread': '43.7', 'groupId': 'OG001'}, {'value': '6.26', 'spread': '31.0', 'groupId': 'OG002'}, {'value': '6.65', 'spread': '27.7', 'groupId': 'OG003'}, {'value': '9.04', 'spread': '21.9', 'groupId': 'OG004'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '7.40', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '8.85', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '7.04', 'spread': '17.0', 'groupId': 'OG002'}, {'value': '7.29', 'spread': '16.7', 'groupId': 'OG003'}, {'value': '6.25', 'spread': '20.6', 'groupId': 'OG004'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '2.29', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '2.92', 'spread': '23.0', 'groupId': 'OG002'}, {'value': '2.99', 'spread': '31.9', 'groupId': 'OG003'}, {'value': '4.15', 'spread': '29.3', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.', 'description': 'Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '0.003', 'spread': '127.6', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '127.4', 'groupId': 'OG001'}, {'value': '0.003', 'spread': '107.5', 'groupId': 'OG002'}, {'value': '0.004', 'spread': '84.9', 'groupId': 'OG003'}, {'value': '0.011', 'spread': '228.5', 'groupId': 'OG004'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '0.91', 'spread': '67.6', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '77.5', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '44.2', 'groupId': 'OG002'}, {'value': '1.35', 'spread': '95.5', 'groupId': 'OG003'}, {'value': '0.98', 'spread': '27.9', 'groupId': 'OG004'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.055', 'spread': '39.5', 'groupId': 'OG000'}, {'value': '0.046', 'spread': '48.3', 'groupId': 'OG001'}, {'value': '0.058', 'spread': '36.7', 'groupId': 'OG002'}, {'value': '0.060', 'spread': '18.3', 'groupId': 'OG003'}, {'value': '0.084', 'spread': '35.0', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.', 'description': 'Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had at Least One Adverse Event Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '100.0'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '80.0', 'groupId': 'OG003', 'lowerLimit': '44.4', 'upperLimit': '97.5'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '17.30', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '25.1'}, {'value': '18.90', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '24.2'}, {'value': '17.20', 'groupId': 'OG002', 'lowerLimit': '14.8', 'upperLimit': '20'}, {'value': '19.50', 'groupId': 'OG003', 'lowerLimit': '16.6', 'upperLimit': '22.9'}, {'value': '26.10', 'groupId': 'OG004', 'lowerLimit': '22.5', 'upperLimit': '30.2'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '82.20', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '103'}, {'value': '86.90', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '100'}, {'value': '71.50', 'groupId': 'OG002', 'lowerLimit': '62.1', 'upperLimit': '82.2'}, {'value': '81.60', 'groupId': 'OG003', 'lowerLimit': '70.8', 'upperLimit': '94.2'}, {'value': '72.60', 'groupId': 'OG004', 'lowerLimit': '64.9', 'upperLimit': '81.1'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '9.97', 'groupId': 'OG000', 'lowerLimit': '7.12', 'upperLimit': '14'}, {'value': '14.90', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '20.9'}, {'value': '13.60', 'groupId': 'OG002', 'lowerLimit': '11.6', 'upperLimit': '15.8'}, {'value': '13.10', 'groupId': 'OG003', 'lowerLimit': '11.2', 'upperLimit': '15.2'}, {'value': '20.30', 'groupId': 'OG004', 'lowerLimit': '16.9', 'upperLimit': '24.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'ug*h/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.021'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.007', 'upperLimit': '0.042'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.008', 'upperLimit': '0.021'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0.004', 'upperLimit': '0.015'}, {'value': '0.02', 'groupId': 'OG004', 'lowerLimit': '0.010', 'upperLimit': '0.038'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.74'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.82'}, {'value': '0.71', 'groupId': 'OG002', 'lowerLimit': '0.478', 'upperLimit': '1.05'}, {'value': '1.09', 'groupId': 'OG003', 'lowerLimit': '0.761', 'upperLimit': '1.56'}, {'value': '1.01', 'groupId': 'OG004', 'lowerLimit': '0.772', 'upperLimit': '1.32'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0.003', 'upperLimit': '0.015'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.085'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.006', 'upperLimit': '0.04'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0.003', 'upperLimit': '0.028'}, {'value': '0.02', 'groupId': 'OG004', 'lowerLimit': '0.008', 'upperLimit': '0.074'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'ug/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0.003', 'upperLimit': '0.018'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.007', 'upperLimit': '0.042'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.007', 'upperLimit': '0.024'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0.004', 'upperLimit': '0.018'}, {'value': '0.02', 'groupId': 'OG004', 'lowerLimit': '0.010', 'upperLimit': '0.040'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.74'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.82'}, {'value': '0.71', 'groupId': 'OG002', 'lowerLimit': '0.48', 'upperLimit': '1.05'}, {'value': '1.09', 'groupId': 'OG003', 'lowerLimit': '0.76', 'upperLimit': '1.56'}, {'value': '1.01', 'groupId': 'OG004', 'lowerLimit': '0.77', 'upperLimit': '1.32'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '0.047'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.005', 'upperLimit': '0.053'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.005', 'upperLimit': '0.021'}, {'value': '0.02', 'groupId': 'OG003', 'lowerLimit': '0.007', 'upperLimit': '0.043'}, {'value': '0.03', 'groupId': 'OG004', 'lowerLimit': '0.008', 'upperLimit': '0.081'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'ug/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included.'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '6.04', 'groupId': 'OG000', 'lowerLimit': '4.29', 'upperLimit': '8.51'}, {'value': '7.42', 'groupId': 'OG001', 'lowerLimit': '5.75', 'upperLimit': '9.57'}, {'value': '7.07', 'groupId': 'OG002', 'lowerLimit': '5.73', 'upperLimit': '8.73'}, {'value': '8.04', 'groupId': 'OG003', 'lowerLimit': '6.27', 'upperLimit': '10.3'}, {'value': '9.60', 'groupId': 'OG004', 'lowerLimit': '8.03', 'upperLimit': '11.5'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '6.79', 'groupId': 'OG000', 'lowerLimit': '5.92', 'upperLimit': '7.8'}, {'value': '6.63', 'groupId': 'OG001', 'lowerLimit': '5.96', 'upperLimit': '7.37'}, {'value': '6.36', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '6.85'}, {'value': '6.59', 'groupId': 'OG003', 'lowerLimit': '6.13', 'upperLimit': '7.09'}, {'value': '5.43', 'groupId': 'OG004', 'lowerLimit': '4.91', 'upperLimit': '6.02'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '2.29', 'groupId': 'OG000', 'lowerLimit': '1.82', 'upperLimit': '2.88'}, {'value': '2.64', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '3.29'}, {'value': '2.98', 'groupId': 'OG002', 'lowerLimit': '2.65', 'upperLimit': '3.35'}, {'value': '2.65', 'groupId': 'OG003', 'lowerLimit': '2.16', 'upperLimit': '3.25'}, {'value': '3.59', 'groupId': 'OG004', 'lowerLimit': '2.89', 'upperLimit': '4.45'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'ug/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '2.50', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '6.00'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '8.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '10.40', 'groupId': 'OG000', 'lowerLimit': '7.16', 'upperLimit': '15.1'}, {'value': '12.70', 'groupId': 'OG001', 'lowerLimit': '9.92', 'upperLimit': '16.3'}, {'value': '17.40', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '20.2'}, {'value': '18.40', 'groupId': 'OG003', 'lowerLimit': '15.7', 'upperLimit': '21.7'}, {'value': '23.00', 'groupId': 'OG004', 'lowerLimit': '19.8', 'upperLimit': '26.6'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.15', 'upperLimit': '0.23'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.27'}, {'value': '0.35', 'groupId': 'OG002', 'lowerLimit': '0.30', 'upperLimit': '0.40'}, {'value': '0.37', 'groupId': 'OG003', 'lowerLimit': '0.32', 'upperLimit': '0.42'}, {'value': '0.69', 'groupId': 'OG004', 'lowerLimit': '0.62', 'upperLimit': '0.77'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '9.03', 'groupId': 'OG000', 'lowerLimit': '6.45', 'upperLimit': '12.6'}, {'value': '8.04', 'groupId': 'OG001', 'lowerLimit': '5.74', 'upperLimit': '11.3'}, {'value': '11.00', 'groupId': 'OG002', 'lowerLimit': '9.46', 'upperLimit': '12.9'}, {'value': '13.80', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '16'}, {'value': '14.80', 'groupId': 'OG004', 'lowerLimit': '12.3', 'upperLimit': '17.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'L/hour', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included'}, {'type': 'SECONDARY', 'title': 'Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'ABC', 'categories': [{'measurements': [{'value': '3.21', 'groupId': 'OG000', 'lowerLimit': '2.54', 'upperLimit': '4.07'}, {'value': '3.43', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '4.34'}, {'value': '3.72', 'groupId': 'OG002', 'lowerLimit': '3.19', 'upperLimit': '4.33'}, {'value': '3.32', 'groupId': 'OG003', 'lowerLimit': '2.75', 'upperLimit': '4.01'}, {'value': '3.30', 'groupId': 'OG004', 'lowerLimit': '2.75', 'upperLimit': '3.97'}]}]}, {'title': 'DTG', 'categories': [{'measurements': [{'value': '8.34', 'groupId': 'OG000', 'lowerLimit': '6.68', 'upperLimit': '10.4'}, {'value': '9.42', 'groupId': 'OG001', 'lowerLimit': '7.91', 'upperLimit': '11.2'}, {'value': '6.75', 'groupId': 'OG002', 'lowerLimit': '5.82', 'upperLimit': '7.83'}, {'value': '8.34', 'groupId': 'OG003', 'lowerLimit': '6.72', 'upperLimit': '10.4'}, {'value': '8.14', 'groupId': 'OG004', 'lowerLimit': '7', 'upperLimit': '9.46'}]}]}, {'title': '3TC', 'categories': [{'measurements': [{'value': '3.38', 'groupId': 'OG000', 'lowerLimit': '2.54', 'upperLimit': '4.48'}, {'value': '3.23', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '4.16'}, {'value': '2.97', 'groupId': 'OG002', 'lowerLimit': '2.52', 'upperLimit': '3.49'}, {'value': '3.46', 'groupId': 'OG003', 'lowerLimit': '2.64', 'upperLimit': '4.52'}, {'value': '3.51', 'groupId': 'OG004', 'lowerLimit': '2.64', 'upperLimit': '4.66'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Adverse Event Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '100.0'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG004', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Adverse Event Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '100.0'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG004', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '21.8'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '30.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Virologic Failure Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'ART-experienced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'ART-naive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced Virologic Failure Through Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'ART-experienced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}]}]}, {'title': 'ART-naive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24. One participant in Weight Band #4 discontinued study treatment between Weeks 24 and 48, so this participant was excluded from analysis at Week 48.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '99.8'}, {'value': '86.7', 'groupId': 'OG002', 'lowerLimit': '59.5', 'upperLimit': '98.3'}, {'value': '80.0', 'groupId': 'OG003', 'lowerLimit': '44.4', 'upperLimit': '97.5'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}, {'value': '83.3', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '97.9'}, {'value': '93.3', 'groupId': 'OG002', 'lowerLimit': '68.1', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '71.5', 'upperLimit': '100.0'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '90.1'}, {'value': '86.7', 'groupId': 'OG002', 'lowerLimit': '59.5', 'upperLimit': '98.3'}, {'value': '70.0', 'groupId': 'OG003', 'lowerLimit': '34.8', 'upperLimit': '93.3'}, {'value': '90.9', 'groupId': 'OG004', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Median (Q1, Q3) CD4+ Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3528', 'groupId': 'OG000', 'lowerLimit': '1458', 'upperLimit': '4457'}, {'value': '1385', 'groupId': 'OG001', 'lowerLimit': '1020', 'upperLimit': '1761'}, {'value': '812', 'groupId': 'OG002', 'lowerLimit': '716', 'upperLimit': '1164'}, {'value': '992', 'groupId': 'OG003', 'lowerLimit': '930', 'upperLimit': '1408'}, {'value': '841', 'groupId': 'OG004', 'lowerLimit': '627', 'upperLimit': '1238'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2208', 'groupId': 'OG000', 'lowerLimit': '1302', 'upperLimit': '2939'}, {'value': '1184', 'groupId': 'OG001', 'lowerLimit': '987', 'upperLimit': '1810'}, {'value': '894', 'groupId': 'OG002', 'lowerLimit': '689', 'upperLimit': '1250'}, {'value': '944', 'groupId': 'OG003', 'lowerLimit': '774', 'upperLimit': '1047'}, {'value': '920', 'groupId': 'OG004', 'lowerLimit': '675', 'upperLimit': '1188'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1853', 'groupId': 'OG000', 'lowerLimit': '1287', 'upperLimit': '2700'}, {'value': '1235', 'groupId': 'OG001', 'lowerLimit': '889', 'upperLimit': '1591'}, {'value': '930', 'groupId': 'OG002', 'lowerLimit': '791', 'upperLimit': '1274'}, {'value': '942', 'groupId': 'OG003', 'lowerLimit': '765', 'upperLimit': '1194'}, {'value': '777', 'groupId': 'OG004', 'lowerLimit': '681', 'upperLimit': '825'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Median (Q1, Q3) CD4+ Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '31.4', 'upperLimit': '43.6'}, {'value': '33.9', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '39.5'}, {'value': '32.4', 'groupId': 'OG002', 'lowerLimit': '27.8', 'upperLimit': '39.7'}, {'value': '34.4', 'groupId': 'OG003', 'lowerLimit': '30.0', 'upperLimit': '41.0'}, {'value': '39.5', 'groupId': 'OG004', 'lowerLimit': '38.2', 'upperLimit': '41.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '29.3', 'upperLimit': '40.3'}, {'value': '35.2', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '40.0'}, {'value': '33.5', 'groupId': 'OG002', 'lowerLimit': '25.9', 'upperLimit': '40.1'}, {'value': '37.7', 'groupId': 'OG003', 'lowerLimit': '27.0', 'upperLimit': '42.0'}, {'value': '38.6', 'groupId': 'OG004', 'lowerLimit': '36.0', 'upperLimit': '44.1'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '29.5', 'upperLimit': '42.6'}, {'value': '34.1', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '39.9'}, {'value': '30.5', 'groupId': 'OG002', 'lowerLimit': '29.3', 'upperLimit': '41.0'}, {'value': '33.5', 'groupId': 'OG003', 'lowerLimit': '28.5', 'upperLimit': '37.0'}, {'value': '37.6', 'groupId': 'OG004', 'lowerLimit': '34.0', 'upperLimit': '41.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.', 'unitOfMeasure': 'percentage of CD4+ in total lymphocytes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Median (Q1,Q3) Change From Baseline in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.31', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '0.68'}, {'value': '-0.70', 'groupId': 'OG001', 'lowerLimit': '-1.40', 'upperLimit': '0.49'}, {'value': '-0.67', 'groupId': 'OG002', 'lowerLimit': '-0.94', 'upperLimit': '0.16'}, {'value': '-0.32', 'groupId': 'OG003', 'lowerLimit': '-0.65', 'upperLimit': '0.34'}, {'value': '-0.18', 'groupId': 'OG004', 'lowerLimit': '-0.67', 'upperLimit': '0.10'}]}]}, {'title': 'Baseline to Week 48', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.84', 'upperLimit': '0.67'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-1.30', 'upperLimit': '0.01'}, {'value': '-0.68', 'groupId': 'OG002', 'lowerLimit': '-1.10', 'upperLimit': '-0.39'}, {'value': '-0.25', 'groupId': 'OG003', 'lowerLimit': '-0.73', 'upperLimit': '0.23'}, {'value': '-0.09', 'groupId': 'OG004', 'lowerLimit': '-0.39', 'upperLimit': '0.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Median (Q1,Q3) Change From Baseline in HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.24'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.40', 'upperLimit': '0.10'}, {'value': '-0.19', 'groupId': 'OG002', 'lowerLimit': '-0.30', 'upperLimit': '0.00'}, {'value': '-0.15', 'groupId': 'OG003', 'lowerLimit': '-0.40', 'upperLimit': '0.20'}, {'value': '-0.06', 'groupId': 'OG004', 'lowerLimit': '-0.18', 'upperLimit': '0.16'}]}]}, {'title': 'Baseline to Week 48', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.26', 'upperLimit': '0.18'}, {'value': '-0.20', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '0.10'}, {'value': '-0.24', 'groupId': 'OG002', 'lowerLimit': '-0.37', 'upperLimit': '-0.08'}, {'value': '-0.19', 'groupId': 'OG003', 'lowerLimit': '-0.50', 'upperLimit': '0.33'}, {'value': '0.05', 'groupId': 'OG004', 'lowerLimit': '-0.01', 'upperLimit': '0.13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Median (Q1,Q3) Change From Baseline in LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Baseline to Week 24', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '-0.78', 'upperLimit': '0.52'}, {'value': '-0.20', 'groupId': 'OG001', 'lowerLimit': '-0.70', 'upperLimit': '0.31'}, {'value': '-0.26', 'groupId': 'OG002', 'lowerLimit': '-0.70', 'upperLimit': '0.11'}, {'value': '-0.22', 'groupId': 'OG003', 'lowerLimit': '-0.60', 'upperLimit': '0.25'}, {'value': '-0.21', 'groupId': 'OG004', 'lowerLimit': '-0.73', 'upperLimit': '-0.03'}]}]}, {'title': 'Baseline to Week 48', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '1.14'}, {'value': '-0.13', 'groupId': 'OG001', 'lowerLimit': '-1.20', 'upperLimit': '0.42'}, {'value': '-0.30', 'groupId': 'OG002', 'lowerLimit': '-0.60', 'upperLimit': '0.10'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-0.18', 'upperLimit': '0.13'}, {'value': '0.03', 'groupId': 'OG004', 'lowerLimit': '-0.41', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Median (Q1,Q3) Change From Baseline in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Baseline to Week 24', 'categories': [{'measurements': [{'value': '-0.51', 'groupId': 'OG000', 'lowerLimit': '-1.28', 'upperLimit': '0.06'}, {'value': '-0.51', 'groupId': 'OG001', 'lowerLimit': '-0.80', 'upperLimit': '-0.13'}, {'value': '-0.17', 'groupId': 'OG002', 'lowerLimit': '-0.58', 'upperLimit': '0.32'}, {'value': '-0.20', 'groupId': 'OG003', 'lowerLimit': '-0.38', 'upperLimit': '0.16'}, {'value': '-0.24', 'groupId': 'OG004', 'lowerLimit': '-0.73', 'upperLimit': '0.89'}]}]}, {'title': 'Baseline to Week 48', 'categories': [{'measurements': [{'value': '-0.43', 'groupId': 'OG000', 'lowerLimit': '-0.97', 'upperLimit': '0.07'}, {'value': '-0.32', 'groupId': 'OG001', 'lowerLimit': '-0.90', 'upperLimit': '0.30'}, {'value': '-0.21', 'groupId': 'OG002', 'lowerLimit': '-0.60', 'upperLimit': '0.20'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-0.31', 'upperLimit': '0.10'}, {'value': '-0.27', 'groupId': 'OG004', 'lowerLimit': '-1.27', 'upperLimit': '-0.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Percent Adherence to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '95.0', 'upperLimit': '100.0'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '90.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '90.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '95.0', 'upperLimit': '100.0'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '90.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '85.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '99.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.', 'unitOfMeasure': 'percentage of study drug taken', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Number of Missed Doses of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.', 'unitOfMeasure': 'missed doses', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Reason for Missed Doses of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Both parents were admitted in the hospital', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Caregiver too sick', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Caregiver was too busy to give the medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Change in daily routine', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Forgot to administer medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Mom was in a hurry and forgot to give child medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Tried to spit it out because of taste (away from caregiver)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'No missed doses', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Both parents were admitted in the hospital', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Caregiver too sick', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Caregiver was too busy to give the medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Change in daily routine', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Forgot to administer medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Mom was in a hurry and forgot to give child medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Tried to spit it out because of taste (away from caregiver)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'No missed doses', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Both parents were admitted in the hospital', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Caregiver too sick', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Caregiver was too busy to give the medication', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Change in daily routine', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Forgot to administer medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Mom was in a hurry and forgot to give child medication', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Tried to spit it out because of taste (away from caregiver)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'No missed doses', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48. All other instances of missing data were due to participants with no missed doses not responding to this question specifying the reason.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'Very good', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'Very good', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Fair', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'title': 'Very good', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Fair', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Poor', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Always', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Almost always', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Usually', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Sometimes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Never', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Always', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'Almost always', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Usually', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Sometimes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Never', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Always', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'title': 'Almost always', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Usually', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Sometimes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Never', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Ease of Giving Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'The child takes by themselves easily', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'The child takes easily with help', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'The child takes with help but you need to threaten, bribe, or promise a reward', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'You need to hold and force the child', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'The child takes by themselves easily', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'The child takes easily with help', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'The child takes with help but you need to threaten, bribe, or promise a reward', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'You need to hold and force the child', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'The child takes by themselves easily', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'The child takes easily with help', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'The child takes with help but you need to threaten, bribe, or promise a reward', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'You need to hold and force the child', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'The child takes by themselves easily', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'The child takes easily with help', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'The child takes with help but you need to threaten, bribe, or promise a reward', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'You need to hold and force the child', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': 'Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': "Parent/Guardian-reported Response of Child's Face When Taking Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': "Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': "Parent/Guardian-reported Response of Child's Face When Taking Favorite Food", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'title': 'Good', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Average', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Very bad', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': "Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Time for Study Drug Tablets to Dissolve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Less than 1 minute', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '1 to less than 3 minutes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': '3 to 5 minutes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Less than 1 minute', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '1 to less than 3 minutes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': '3 to 5 minutes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Less than 1 minute', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': '1 to less than 3 minutes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': '3 to 5 minutes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Less than 1 minute', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '1 to less than 3 minutes', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '3 to 5 minutes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': 'Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.'}, {'type': 'SECONDARY', 'title': 'Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'It is acceptable', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'It is too many', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'It is too few', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'It is acceptable', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'It is too many', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'It is too few', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'It is acceptable', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'It is too many', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'It is too few', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'title': 'It is acceptable', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'It is too many', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'It is too few', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': 'Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.'}, {'type': 'SECONDARY', 'title': 'Antiretroviral (ARV) Resistance Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'OG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'classes': [{'title': 'Entry Visit: Integrase K14R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase A21T', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V31I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V72I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase L74I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase T112V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V113I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase T125A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V126L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase G134N', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase I135V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase K136R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V165I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase A196P', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V236I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase V281M', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Integrase S283G', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease L10V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease I13V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease G16E', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease E35D', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease M36I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease R41K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease K43R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease H69K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease I72V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Protease L89M', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase E6D', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K11T', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K20R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase V35T', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase T39K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K43E', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase Q102K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K122E', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase D123S', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase C162S', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase T165I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K173A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase Q174K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase D177E', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase T200A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase I202V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase Q207A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase L210M', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase R211S', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase V245E', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase A272P', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase R277K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase T286A', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase L295L/I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase E312N', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase I326V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase I329V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase G335D', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase M357K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K358R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase G359S', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K366R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase A371V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase T377S', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K390R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase K395R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Entry Visit: Reverse Transcriptase A400T', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Entry and confirmation of virologic failure', 'description': 'ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants experiencing confirmed virologic failure. Due to assay limitations, mutation results could not be obtained from the specimen collected at the virologic failure confirmation visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'FG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'FG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'FG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'FG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}], 'periods': [{'title': 'Main Study (Through Week 48)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extended Follow-up (Weeks 48 Through 60)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Accrual occurred between September 2020 and June 2021 in Botswana, South Africa, Thailand, and the United States at 14 different medical clinic sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Weight Band #1 (6 to Less Than 10 kg at Study Entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'BG001', 'title': 'Weight Band #2 (10 to Less Than 14 kg at Study Entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'BG002', 'title': 'Weight Band #3 (14 to Less Than 20 kg at Study Entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'BG003', 'title': 'Weight Band #4 (20 to Less Than 25 kg at Study Entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food'}, {'id': 'BG004', 'title': 'Weight Band #5 (25 kg or Greater at Study Entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.\n\nAbacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1.35', 'groupId': 'BG000', 'lowerLimit': '0.98', 'upperLimit': '2.02'}, {'value': '3.56', 'groupId': 'BG001', 'lowerLimit': '1.51', 'upperLimit': '4.51'}, {'value': '6.44', 'groupId': 'BG002', 'lowerLimit': '3.88', 'upperLimit': '9.58'}, {'value': '8.41', 'groupId': 'BG003', 'lowerLimit': '6.38', 'upperLimit': '8.91'}, {'value': '9.74', 'groupId': 'BG004', 'lowerLimit': '8.68', 'upperLimit': '11.28'}, {'value': '6.38', 'groupId': 'BG005', 'lowerLimit': '0.98', 'upperLimit': '11.28'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<6 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}]}]}, {'title': '6 to <12 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}, {'title': 'Botswana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'BG000', 'lowerLimit': '8.5', 'upperLimit': '9.5'}, {'value': '12.9', 'groupId': 'BG001', 'lowerLimit': '12.5', 'upperLimit': '13.7'}, {'value': '17.0', 'groupId': 'BG002', 'lowerLimit': '15.9', 'upperLimit': '18.8'}, {'value': '21.5', 'groupId': 'BG003', 'lowerLimit': '21.0', 'upperLimit': '23.3'}, {'value': '28.5', 'groupId': 'BG004', 'lowerLimit': '26.0', 'upperLimit': '35.6'}, {'value': '17.0', 'groupId': 'BG005', 'lowerLimit': '12.8', 'upperLimit': '22.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pre-study Antiretroviral (ART) experience', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'title': 'ART-experienced', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '54', 'groupId': 'BG005'}]}, {'title': 'ART-naive', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Known M184V mutation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'title': '<200 copies/mL', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}]}, {'title': '≥200 copies/mL', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.', 'unitOfMeasure': 'Participants'}, {'title': 'CD4+ Cell Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2321', 'groupId': 'BG000', 'lowerLimit': '1390', 'upperLimit': '3514'}, {'value': '1452', 'groupId': 'BG001', 'lowerLimit': '1161', 'upperLimit': '2615'}, {'value': '886', 'groupId': 'BG002', 'lowerLimit': '761', 'upperLimit': '1412'}, {'value': '1155', 'groupId': 'BG003', 'lowerLimit': '801', 'upperLimit': '1251'}, {'value': '915', 'groupId': 'BG004', 'lowerLimit': '753', 'upperLimit': '1450'}, {'value': '1201', 'groupId': 'BG005', 'lowerLimit': '880', 'upperLimit': '1535'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'CD4 was not collected at baseline for one participant in Weight Band #2.'}, {'title': 'CD4+ Percentage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'BG000', 'lowerLimit': '32.3', 'upperLimit': '49.1'}, {'value': '33.9', 'groupId': 'BG001', 'lowerLimit': '31.6', 'upperLimit': '45.6'}, {'value': '32.9', 'groupId': 'BG002', 'lowerLimit': '31.6', 'upperLimit': '39.2'}, {'value': '32.6', 'groupId': 'BG003', 'lowerLimit': '26.2', 'upperLimit': '43.0'}, {'value': '37.7', 'groupId': 'BG004', 'lowerLimit': '35.6', 'upperLimit': '43.0'}, {'value': '35.1', 'groupId': 'BG005', 'lowerLimit': '31.9', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage of CD4+ in total lymphocytes', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.'}, {'title': 'Total Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '4.01', 'groupId': 'BG000', 'lowerLimit': '3.19', 'upperLimit': '4.82'}, {'value': '4.61', 'groupId': 'BG001', 'lowerLimit': '3.39', 'upperLimit': '5.11'}, {'value': '4.51', 'groupId': 'BG002', 'lowerLimit': '3.70', 'upperLimit': '5.20'}, {'value': '5.19', 'groupId': 'BG003', 'lowerLimit': '3.86', 'upperLimit': '5.90'}, {'value': '4.27', 'groupId': 'BG004', 'lowerLimit': '3.25', 'upperLimit': '5.72'}, {'value': '4.51', 'groupId': 'BG005', 'lowerLimit': '3.57', 'upperLimit': '5.30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'High-Density Lipoprotein (HDL) Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'BG000', 'lowerLimit': '0.96', 'upperLimit': '1.18'}, {'value': '1.53', 'groupId': 'BG001', 'lowerLimit': '1.29', 'upperLimit': '1.63'}, {'value': '1.38', 'groupId': 'BG002', 'lowerLimit': '1.24', 'upperLimit': '1.79'}, {'value': '1.67', 'groupId': 'BG003', 'lowerLimit': '1.14', 'upperLimit': '2.00'}, {'value': '1.34', 'groupId': 'BG004', 'lowerLimit': '1.13', 'upperLimit': '1.53'}, {'value': '1.37', 'groupId': 'BG005', 'lowerLimit': '1.1914', 'upperLimit': '1.67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Low-Density Lipoprotein (LDL) Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2.52', 'groupId': 'BG000', 'lowerLimit': '1.92', 'upperLimit': '3.20'}, {'value': '2.25', 'groupId': 'BG001', 'lowerLimit': '2.00', 'upperLimit': '3.01'}, {'value': '2.50', 'groupId': 'BG002', 'lowerLimit': '1.94', 'upperLimit': '3.03'}, {'value': '3.04', 'groupId': 'BG003', 'lowerLimit': '2.31', 'upperLimit': '3.55'}, {'value': '2.36', 'groupId': 'BG004', 'lowerLimit': '1.79', 'upperLimit': '3.09'}, {'value': '2.52', 'groupId': 'BG005', 'lowerLimit': '1.93', 'upperLimit': '3.10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Triglycerides', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'BG000', 'lowerLimit': '1.04', 'upperLimit': '2.00'}, {'value': '1.20', 'groupId': 'BG001', 'lowerLimit': '0.94', 'upperLimit': '1.75'}, {'value': '1.23', 'groupId': 'BG002', 'lowerLimit': '0.90', 'upperLimit': '1.57'}, {'value': '1.08', 'groupId': 'BG003', 'lowerLimit': '0.81', 'upperLimit': '1.32'}, {'value': '1.76', 'groupId': 'BG004', 'lowerLimit': '0.75', 'upperLimit': '2.88'}, {'value': '1.20', 'groupId': 'BG005', 'lowerLimit': '0.90', 'upperLimit': '1.76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'All enrolled participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-14', 'size': 1852601, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-09T15:03', 'hasProtocol': True}, {'date': '2019-12-05', 'size': 219052, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-09T12:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2018-11-29', 'resultsFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-18', 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC', 'timeFrame': 'Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.', 'description': 'Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug\\*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.'}, {'measure': 'Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC', 'timeFrame': 'Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.', 'description': 'Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.'}, {'measure': 'Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC', 'timeFrame': 'Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.', 'description': 'Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.'}, {'measure': 'Percentage of Participants Who Had at Least One Adverse Event Through Week 24', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.'}, {'measure': 'Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).'}, {'measure': 'Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.'}, {'measure': 'Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24', 'timeFrame': 'Measured from treatment initiation through Week 24', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}], 'secondaryOutcomes': [{'measure': 'Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC', 'timeFrame': 'Measured from Week 1 through Week 48 over 24 hours post-dose', 'description': 'Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.'}, {'measure': 'Percentage of Participants With at Least One Adverse Event Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.'}, {'measure': 'Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.'}, {'measure': 'Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.'}, {'measure': 'Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had at Least One Adverse Event Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.'}, {'measure': 'Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.'}, {'measure': 'Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.'}, {'measure': 'Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.'}, {'measure': 'Percentage of Participants Who Experienced Virologic Failure Through Week 48', 'timeFrame': 'Measured from treatment initiation through Week 48', 'description': 'Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.'}, {'measure': 'Percentage of Participants Who Experienced Virologic Failure Through Week 60', 'timeFrame': 'Measured from treatment initiation through Week 60', 'description': 'Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.'}, {'measure': 'Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.'}, {'measure': 'Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.'}, {'measure': 'Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.'}, {'measure': 'Median (Q1, Q3) CD4+ Cell Count', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.'}, {'measure': 'Median (Q1, Q3) CD4+ Percentage', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.'}, {'measure': 'Median (Q1,Q3) Change From Baseline in Total Cholesterol', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.'}, {'measure': 'Median (Q1,Q3) Change From Baseline in HDL', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.'}, {'measure': 'Median (Q1,Q3) Change From Baseline in LDL', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.'}, {'measure': 'Median (Q1,Q3) Change From Baseline in Triglycerides', 'timeFrame': 'Baseline, Weeks 24 and 48', 'description': 'Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.'}, {'measure': 'Parent/Guardian-reported Percent Adherence to Study Drug', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.'}, {'measure': 'Parent/Guardian-reported Number of Missed Doses of Study Drug', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.'}, {'measure': 'Parent/Guardian-reported Reason for Missed Doses of Study Drug', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.'}, {'measure': 'Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.'}, {'measure': 'Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to', 'timeFrame': 'Weeks 4, 24, and 48', 'description': 'Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.'}, {'measure': 'Parent/Guardian-reported Ease of Giving Study Drug', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': 'Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.'}, {'measure': "Parent/Guardian-reported Response of Child's Face When Taking Study Drug", 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': "Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses."}, {'measure': "Parent/Guardian-reported Response of Child's Face When Taking Favorite Food", 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': "Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses."}, {'measure': 'Parent/Guardian-reported Time for Study Drug Tablets to Dissolve', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': 'Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses'}, {'measure': 'Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve', 'timeFrame': 'Weeks 4, 12, 24, and 48', 'description': 'Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses'}, {'measure': 'Antiretroviral (ARV) Resistance Mutations', 'timeFrame': 'Entry and confirmation of virologic failure', 'description': 'ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '37541705', 'type': 'DERIVED', 'citation': 'Brooks KM, Kiser JJ, Ziemba L, Ward S, Rani Y, Cressey TR, Masheto GR, Cassim H, Deville JG, Ponatshego PL, Patel F, Aurpibul L, Barnabas SL, Mustich I, Coletti A, Heckman B, Krotje C, Lojacono M, Yin DE, Townley E, Moye J, Majji S, Acosta EP, Ryan K, Chandasana H, Brothers CH, Buchanan AM, Rabie H, Flynn PM; IMPAACT 2019 Study Team. Pharmacokinetics, safety, and tolerability of dispersible and immediate-release abacavir, dolutegravir, and lamivudine tablets in children with HIV (IMPAACT 2019): week 24 results of an open-label, multicentre, phase 1-2 dose-confirmation study. Lancet HIV. 2023 Aug;10(8):e506-e517. doi: 10.1016/S2352-3018(23)00107-8.'}, {'pmid': '34817414', 'type': 'DERIVED', 'citation': 'Singh RP, Adkison KK, Baker M, Parasrampuria R, Wolstenholme A, Davies M, Sewell N, Brothers C, Buchanan AM. Development of Dolutegravir Single-entity and Fixed-dose Combination Formulations for Children. Pediatr Infect Dis J. 2022 Mar 1;41(3):230-237. doi: 10.1097/INF.0000000000003366.'}], 'seeAlsoLinks': [{'url': 'https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables', 'label': 'The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1 (July 2017)'}, {'url': 'http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids', 'label': 'Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010'}, {'url': 'https://www.fda.gov/files/drugs/published/Human-Immunodeficiency-Virus-1-Infection--Developing-Antiretroviral-Drugs-for-Treatment.pdf', 'label': 'FDA Snapshot Algorithm'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.', 'detailedDescription': "This study examined the pharmacokinetics (PK), safety, and tolerability of fixed-dose combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate release tablets in children living with HIV less than 12 years of age.\n\nChildren were enrolled into one of five ABC/DTG/3TC dosing groups based on their weight. The first 5-7 children within each weight-band underwent intensive PK assessments 5-10 days after starting ABC/DTG/3TC to confirm dose selection. Children remained on their initial dose of ABC/DTG/3TC through Week 4. After Week 4, ABC/DTG/3TC dosing was adjusted based on PK results at the individual or weight-band level, and/or an individual child's growth and weight gain over time.\n\nFollow-up study visits for all participants occurred at Weeks 1, 4, 12, 24, 36, and 48. If participants had a known M184 resistance mutation, they had additional study visits at Weeks 8, 16, and 20. Study visits included physical examination, study drug adherence and tolerability questionnaires, blood collection, and intensive PK sampling. Following the Week 48 study visit, some children were allowed to continue follow-up through up to 144 weeks if alternative post-study drug supply was not yet available."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Weight 6 kg to less than 40 kg at entry\n* Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen for at least six consecutive months at entry\n\n * Note: For ART-naïve children, receipt of antiretroviral (ARV) prophylaxis prior to diagnosis of HIV infection is permitted. For these children, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.\n * Note: For ART-experienced children (on a stable ART regimen), dose and formulation changes (e.g., for growth) within the six months prior to entry are permitted. For these children, ascertainment of this criterion must be based on medical records.\n* For ART-experienced children (on a stable ART regimen), has had a suppressed HIV viral load (HIV-1 RNA less than 200 copies/mL) for at least six consecutive months prior to entry\n\n * Note: To fulfill this criterion, at least two documented HIV-1 RNA results less than 200 copies/mL must be available, one based on a specimen collected at least six months prior to entry and one based on a specimen collected within 30 days prior to entry.\n * Note: Any documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry is exclusionary (see exclusion criterion below).\n* At screening, has normal, Grade 1, or Grade 2 laboratory test results for all of the following, based on testing of specimens collected within 30 days prior to entry and grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (refer to the study protocol for guidance on severity grading):\n\n * Hemoglobin (greater than or equal to 8.5 g/dL or greater than or equal to 5.25 mmol/L)\n * Absolute neutrophil count (greater than or equal to 600 cells/mm\\^3 or greater than or equal to 0.600 x 10\\^9 cells/L)\n * Platelet count (greater than or equal to 50,000 cells/mm\\^3 or greater than or equal to 50.00 x 10\\^9 cells/L)\n * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula; greater than or equal to 60 ml/min/1.73 m\\^2)\n * Alanine transaminase (ALT) (less than 5.0 x ULN)\n * Aspartate aminotransferase (AST) (less than 5.0 x ULN)\n * Total bilirubin (less than 2.6 x ULN)\n * Direct bilirubin (less than or equal to ULN)\n * Note: Laboratory tests may be repeated during the screening period (i.e., within 30 days prior to entry), with the latest results used for eligibility determination.\n * Note: For treatment-experienced children on an atazanavir-containing ART regimen, Grade 3 or higher total bilirubin is permitted.\n* At screening, has a negative test result for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry\n* Confirmed HIV-1-infection based on documented testing of two samples collected at different time points:\n\n * Sample #1 may be tested using any of the following:\n\n * Two rapid antibody tests from different manufacturers or based on different principles and epitopes\n * One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay\n * One HIV DNA polymerase chain reaction (PCR)\\*\n * One quantitative HIV RNA PCR (above the limit of detection of the assay)\\*\n * One qualitative HIV RNA PCR\\*\n * One HIV total nucleic acid test\\*\n * Sample #2 may be tested using any of the following:\n\n * Rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be United States Food and Drug Administration (FDA)-approved, and the third rapid test must be from a third manufacturer or based on a third principle or epitope.\n * One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay\n * One HIV DNA PCR\\*\n * One quantitative HIV RNA PCR (above the limit of detection of the assay)\\*\n * One qualitative HIV RNA PCR\\*\n * One HIV total nucleic acid test\\*\n * For participants who are less than two years of age, or who are two years of age and older with any exposure to breast milk in the past 28 days, HIV-1 infection must be confirmed using the tests indicated above with an asterisk (\\*) for Sample #1 and Sample #2.\n * Whole blood, plasma, or serum samples must be tested. If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to Good Clinical Laboratory Practice guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing is used, at least one test must be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified (for US sites) or Virology Quality Assurance (VQA) certified (for non-US sites) laboratory. For tests performed in other settings, adequate source documentation including the date of specimen collection, date of testing, test performed, and test result must be available. FDA approved testing methods should be used when possible.\n* HLA-B\\*5701-negative based on documented testing at any time prior to entry\n\n * Note: Documented testing is required even if the potential participant has received ABC prior to study entry.\n* For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening\n* For females of reproductive potential who are engaging in sexual activity that could lead to pregnancy, willing to use two methods of contraception while receiving study drug, based on participant and parent or guardian report at entry\n\n * One of the two methods must be highly effective; highly effective methods include surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) and the following:\n\n * Contraceptive intrauterine device or intrauterine system\n * Subdermal contraceptive implant\n * Progestogen injections\n * Combined estrogen and progestogen oral contraceptive pills\n * Percutaneous contraceptive patch\n * Contraceptive vaginal ring\n * The highly effective method must be initiated prior to study entry. The second method should ideally be a barrier method. Male or female condom use is recommended with all other methods of contraception for dual protection against pregnancy and to avoid transmission of HIV and other sexually transmitted infections.\n* Based on parent or guardian report at entry, child is expected to be available for 48 weeks of follow-up\n* Parent or legal guardian is willing and able to provide written informed consent for child's study participation and, when applicable per local institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written informed assent for study participation\n\nExclusion Criteria:\n\n* Documented resistance to ABC, DTG, or 3TC\n\n * Note: Testing to rule out resistance is not required, and the M184V resistance mutation is not exclusionary.\n* For ART-experienced children (on a stable ART regimen), documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry\n* History of any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records:\n\n * Malignancy (ever)\n * Hypersensitivity reaction to ABC (ever)\n * Receipt of any prohibited medication (refer to the study protocol for more information) within 30 days prior to study entry\n * Receipt of systemic interferon or any chronic systemic immunosuppressant medication within 30 days prior to study entry\n * Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg) taken for replacement or short course therapy are permitted. Intranasal or inhaled steroid use is also permitted.\n* Has any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records\n\n * Current clinical evidence of pancreatitis\n * Currently-active tuberculosis (TB) and/or currently receiving rifampicin-containing TB treatment\n * Currently-active AIDS-defining (WHO Clinical Stage 4) opportunistic infection\n* Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives"}, 'identificationModule': {'nctId': 'NCT03760458', 'briefTitle': 'The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age', 'orgStudyIdInfo': {'id': 'IMPAACT 2019'}, 'secondaryIdInfos': [{'id': '38504', 'type': 'REGISTRY', 'domain': 'DAIDS-ES Registry Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight Band #1 (6 to less than 10 kg at study entry)', 'description': 'Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-\\<10 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'interventionNames': ['Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Weight Band #2 (10 to less than 14 kg at study entry)', 'description': 'Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-\\<14 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'interventionNames': ['Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Weight Band #3 (14 to less than 20 kg at study entry)', 'description': 'Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-\\<20 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'interventionNames': ['Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Weight Band #4 (20 to less than 25 kg at study entry)', 'description': 'Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-\\<25 kg; as their weight increased, they received higher doses consistent with their new weight band.', 'interventionNames': ['Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Weight Band #5 (25 kg or greater at study entry)', 'description': 'Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.', 'interventionNames': ['Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)']}], 'interventions': [{'name': 'Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets', 'type': 'DRUG', 'description': 'Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food', 'armGroupLabels': ['Weight Band #1 (6 to less than 10 kg at study entry)', 'Weight Band #2 (10 to less than 14 kg at study entry)', 'Weight Band #3 (14 to less than 20 kg at study entry)', 'Weight Band #4 (20 to less than 25 kg at study entry)']}, {'name': 'Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)', 'type': 'DRUG', 'otherNames': ['Triumeq'], 'description': 'Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food', 'armGroupLabels': ['Weight Band #5 (25 kg or greater at study entry)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1752', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA NICHD CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ. of Colorado Denver NICHD CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Univ. Cook County Hosp. Chicago NICHD CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614-3393', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital of Chicago (LCH) CRS", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '38105-3678', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital CRS", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Gaborone CRS', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Molepolole CRS', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'zip': '1862', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Soweto IMPAACT CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2001', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Wits RHI Shandukani Research Centre CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '4066', 'city': 'Umlazi', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Umlazi CRS', 'geoPoint': {'lat': -29.96667, 'lon': 30.88333}}, {'zip': '7505', 'city': 'Tygerberg', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Famcru Crs'}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkoknoi', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University NICHD CRS', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50100', 'city': 'Changklan, Muang', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiangrai Prachanukroh Hospital NICHD CRS'}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Patricia Flynn, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Jude Children's Research Hospital"}, {'name': 'Helena Rabie, MBChB, MMED, FCPaed', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Stellenbosch'}, {'name': 'Jennifer Kiser, PharmD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie results in the publication, after deidentification.', 'accessCriteria': '* With whom?\n\n * Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.\n* For what types of analyses?\n\n * To achieve aims in the proposal approved by the IMPAACT Network.\n* By what mechanism will data be made available?\n\n * Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group', 'class': 'NETWORK'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}