Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2026-01-01 @ 2:11 AM
Study NCT ID:
NCT00791700
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Tanzania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 5 years', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 25, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 10, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 34, 'seriousNumAtRisk': 43, 'deathsNumAffected': 1, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Conjunctival pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Refraction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Salivary gland mucocoele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Allergy to arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Bullous impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Gastric fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v18.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Cavg-Week2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '237.34', 'spread': '63', 'groupId': 'OG000'}, {'value': '260.65', 'spread': '43', 'groupId': 'OG001'}, {'value': '264.45', 'spread': '62', 'groupId': 'OG002'}, {'value': '239.85', 'spread': '67', 'groupId': 'OG003'}]}]}, {'title': 'Cavg-Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '163.73', 'spread': '146', 'groupId': 'OG000'}, {'value': '289.69', 'spread': '50', 'groupId': 'OG001'}, {'value': '168.62', 'spread': '117', 'groupId': 'OG002'}, {'value': '199.12', 'spread': '78', 'groupId': 'OG003'}]}]}, {'title': 'Cmax-Week2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '581.47', 'spread': '69', 'groupId': 'OG000'}, {'value': '546.80', 'spread': '51', 'groupId': 'OG001'}, {'value': '444.37', 'spread': '61', 'groupId': 'OG002'}, {'value': '530.80', 'spread': '62', 'groupId': 'OG003'}]}]}, {'title': 'Cmax-Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '334.68', 'spread': '156', 'groupId': 'OG000'}, {'value': '593.68', 'spread': '25', 'groupId': 'OG001'}, {'value': '284.96', 'spread': '128', 'groupId': 'OG002'}, {'value': '423.32', 'spread': '48', 'groupId': 'OG003'}]}]}, {'title': 'Cmin-Week2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.97', 'spread': '202208', 'groupId': 'OG000'}, {'value': '100.02', 'spread': '39', 'groupId': 'OG001'}, {'value': '115.84', 'spread': '90', 'groupId': 'OG002'}, {'value': '56.17', 'spread': '145', 'groupId': 'OG003'}]}]}, {'title': 'Cmin-Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.11', 'spread': '180', 'groupId': 'OG000'}, {'value': '82.21', 'spread': '120', 'groupId': 'OG001'}, {'value': '60.03', 'spread': '245', 'groupId': 'OG002'}, {'value': '66.51', 'spread': '140', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)', 'description': 'Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed": participants evaluable at specified time points for this measure.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve at Steady State (AUCtau)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'AUCtau - Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2848.1', 'spread': '63', 'groupId': 'OG000'}, {'value': '3127.7', 'spread': '43', 'groupId': 'OG001'}, {'value': '3173.4', 'spread': '62', 'groupId': 'OG002'}, {'value': '2878.2', 'spread': '67', 'groupId': 'OG003'}]}]}, {'title': 'AUCtau - Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1964.7', 'spread': '146', 'groupId': 'OG000'}, {'value': '3476.3', 'spread': '50', 'groupId': 'OG001'}, {'value': '2023.5', 'spread': '117', 'groupId': 'OG002'}, {'value': '2389.4', 'spread': '78', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)', 'description': 'AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed" signifies participants evaluable at specified time points for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Tmax - Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '6.00'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '6.00'}, {'value': '2.000', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.000', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'Tmax - Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '6.03'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '8.00'}, {'value': '3.000', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '6.00'}, {'value': '2.000', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set consisted of all enrolled participants who had at least one PK sample with a dosing history. "Number analyzed" signifies participants evaluable at specified time points for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1 (Grade 3)', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': 'Cohort 1 (Grade 4)', 'description': 'In cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20mg/mL).'}, {'id': 'OG002', 'title': 'Cohort 2 (Grade 3)', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG003', 'title': 'Cohort 2 (Grade 4)', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG004', 'title': 'Cohort 3 (Grade 3)', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG005', 'title': 'Cohort 3 (Grade 4)', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG006', 'title': 'Cohort 4 (Grade 3)', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG007', 'title': 'Cohort 4 (Grade 4)', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Gastrointestinal disorders - Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Hepat. disorders - Drug-induced liver injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Infections and infestations - H1N1 influenza', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Infections and infestations - Pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Investigations - Lipase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Pyschiatric disorder - Bipolar disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Gastrointestinal disorders - Gastritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Investigations - Hepatic enzyme abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Investigations - Transaminases increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Pyschiatric disorder - Aggression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Blood and lymphatic system disorders - Anaemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Infections and infestations - Meningitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Infections and infestations -Otitis media', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 5 years', 'description': 'Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was performed on all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 5 years', 'description': 'The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis was performed on all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '90.3', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}, {'value': '62.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}, {'value': '51.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'The proportion of participants who achieved HIV-1 RNA \\<400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration\'s (FDA\'s) Missing, Switch, Discontinuation\'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who receive at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '18.75', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}, {'value': '61.5', 'groupId': 'OG002'}, {'value': '48.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}, {'value': '39.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'The proportion of participants who achieved HIV-1 RNA \\<48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration\'s (FDA\'s) Missing, Switch, Discontinuation\'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '38.8', 'upperLimit': '86.2'}, {'value': '87.10', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '98.9'}, {'value': '69.2', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '94.3'}, {'value': '62.8', 'groupId': 'OG003', 'lowerLimit': '48.3', 'upperLimit': '77.2'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '96.2'}, {'value': '74.2', 'groupId': 'OG001', 'lowerLimit': '58.8', 'upperLimit': '89.6'}, {'value': '69.2', 'groupId': 'OG002', 'lowerLimit': '44.1', 'upperLimit': '94.3'}, {'value': '51.2', 'groupId': 'OG003', 'lowerLimit': '36.2', 'upperLimit': '66.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \\> lower limit of quantification (LLOQ) . This referred to as \\[non-completer = failure; NC=F\\] or \\[missing, discontinuation = failure; MD=F\\].', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this measure."Number analyzed" signifies participants evaluable at specified time points for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '37.9'}, {'value': '64.5', 'groupId': 'OG001', 'lowerLimit': '47.7', 'upperLimit': '81.4'}, {'value': '61.5', 'groupId': 'OG002', 'lowerLimit': '35.1', 'upperLimit': '89.0'}, {'value': '48.8', 'groupId': 'OG003', 'lowerLimit': '33.9', 'upperLimit': '63.8'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': '74.5'}, {'value': '54.8', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '69.2'}, {'value': '53.8', 'groupId': 'OG002', 'lowerLimit': '35.1', 'upperLimit': '89.0'}, {'value': '39.5', 'groupId': 'OG003', 'lowerLimit': '24.9', 'upperLimit': '54.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \\> lower limit of quantification (LLOQ) . This referred as \\[non-completer = failure; NC=F\\] or \\[missing, discontinuation = failure; MD=F\\].', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this measure."Number analyzed" signifies participants evaluable at specified time points for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': '<400 copies/mL; TLOVR Responder', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}, {'value': '69.2', 'groupId': 'OG002'}, {'value': '48.8', 'groupId': 'OG003'}]}]}, {'title': '<48 copies/mL; TLOVR Responder', 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}, {'value': '44.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Baseline to Week 24', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '106.8'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '93.1', 'groupId': 'OG003', 'lowerLimit': '83.9', 'upperLimit': '102.3'}]}]}, {'title': 'Baseline to Week 48', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '103.6'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '100.0', 'upperLimit': '100.0'}, {'value': '88.0', 'groupId': 'OG003', 'lowerLimit': '75.3', 'upperLimit': '100.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24, Week 48 post-treatment', 'description': 'Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. Last Observation Carried Forward (LOCF) was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HIV-1 RNA (Original)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Change from Baseline - Original - Week 24', 'categories': [{'measurements': [{'value': '-271974.6', 'spread': '391843.59', 'groupId': 'OG000'}, {'value': '-38764.0', 'spread': '63688.93', 'groupId': 'OG001'}, {'value': '-58081.0', 'spread': '79720.33', 'groupId': 'OG002'}, {'value': '-57325.7', 'spread': '172108.62', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline - Original - Week 48', 'categories': [{'measurements': [{'value': '-267834.2', 'spread': '378896.88', 'groupId': 'OG000'}, {'value': '-34787.7', 'spread': '60222.60', 'groupId': 'OG001'}, {'value': '-56351.7', 'spread': '76231.03', 'groupId': 'OG002'}, {'value': '-55321.1', 'spread': '173840.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 48 post-treatment', 'description': 'Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \\[LLOQ\\] \\<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \\>1000 copies/ml was used to determine eligibility for the study.', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HIV-1 RNA (Log10 Copies/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Change from Baseline - Log10 - Week 24', 'categories': [{'measurements': [{'value': '-2.4853', 'spread': '1.1421', 'groupId': 'OG000'}, {'value': '-2.2324', 'spread': '0.8668', 'groupId': 'OG001'}, {'value': '-2.1756', 'spread': '1.1854', 'groupId': 'OG002'}, {'value': '-1.6482', 'spread': '1.3806', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline - Log10 - Week 48', 'categories': [{'measurements': [{'value': '-2.5831', 'spread': '1.2148', 'groupId': 'OG000'}, {'value': '-1.9579', 'spread': '1.0861', 'groupId': 'OG001'}, {'value': '-2.0549', 'spread': '1.2125', 'groupId': 'OG002'}, {'value': '-1.4591', 'spread': '1.4477', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 48 post-treatment', 'description': 'Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \\[LLOQ\\] \\<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \\>1000 copies/ml was used to determine eligibility for the study.', 'unitOfMeasure': 'Log10 Copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '232.7', 'spread': '381.6', 'groupId': 'OG000'}, {'value': '355.8', 'spread': '294.0', 'groupId': 'OG001'}, {'value': '213.9', 'spread': '166.4', 'groupId': 'OG002'}, {'value': '173.6', 'spread': '203.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '275.9', 'spread': '363.4', 'groupId': 'OG000'}, {'value': '362.7', 'spread': '373.5', 'groupId': 'OG001'}, {'value': '167.3', 'spread': '150.9', 'groupId': 'OG002'}, {'value': '168.6', 'spread': '211.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 48 post-treatment', 'description': 'Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '7.3', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '6.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '7.5', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '6.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 and Week 48 post-treatment', 'description': 'Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.', 'unitOfMeasure': 'percentage of CD4+ cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. LOCF was used to impute missing values. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Protocol Defined Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'Criteria A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Criteria B', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Criteria C', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA \\<1 log10 and plasma HIV-1 RNA \\>400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA \\<2.0 log10 and plasma HIV-1 RNA \\>400 copies/mL at Week 24 OR plasma HIV-1 RNA \\>10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of \\>=1 log10 (\\>=1,000 copies/mL if nadir plasma HIV-1 RNA \\<48 copies/mL) at any time, and confirmed within 14 to 21 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'With valid on-treatment results', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Tropism at Confirmed PDVF R5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Tropism at Confirmed PDVF DM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Tropism at Confirmed PDVF X4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Tropism at Confirmed PDVF Not Reportable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening to Week 48', 'description': 'Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'OG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'OG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'classes': [{'title': 'With valid on-treatment results', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'PI Minor L10L/F', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PI Minor L89L/I/M', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PI Minor V77V/I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'NNRTI K103K/N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NNRTI K103N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'NRTI M184V', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PI Minor K20K/R', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Total with emergence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Optimized Background Treatment Susceptibility Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Response', 'description': 'Participants with plasma HIV-1 RNA \\<48 copies/mL'}, {'id': 'OG001', 'title': 'PDVF', 'description': 'Participants who meet the protocol-defined virologic failure'}, {'id': 'OG002', 'title': 'Other Failure/Remainder', 'description': 'Participants with other failures'}], 'classes': [{'title': 'Simple score 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Simple score 1.0', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Simple score >=2.0', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}, {'value': '95.7', 'groupId': 'OG001'}, {'value': '96.8', 'groupId': 'OG002'}]}]}, {'title': 'Weighted score 0-0.5', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}, {'value': '29.0', 'groupId': 'OG002'}]}]}, {'title': 'Weighted score 1.0-1.5', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '65.2', 'groupId': 'OG001'}, {'value': '29.0', 'groupId': 'OG002'}]}]}, {'title': 'Weighted score >=2.0', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '38.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, \\>=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and \\>=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 milligram per milliliter \\[mg/mL\\]).'}, {'id': 'FG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 milligram \\[mg\\], 75 mg, 150 mg).'}, {'id': 'FG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'FG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'No longer willing to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Withdrawn due to pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This open-label, multicenter, multiple dose pharmacokinetic, safety and efficacy study at 24 sites in 8 countries.', 'preAssignmentDetails': 'The participants were HIV-1 infected treatment-experienced children and adolescents who were failing current antiretroviral (ARV) therapy or have failed their most recent ARV regimen, defined by plasma HIV-1 RNA\\>=1000 copies/mL, were infected with only R5 HIV-1, and have ARV experience/intolerance of 6 months with at least 2 ARV drug classes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '>=2 - <6 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 1, Participants aged \\>= 2 to \\< 6 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'BG001', 'title': '>=6 - <12 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 2, Participants aged \\>=6 to \\<12 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'BG002', 'title': '>=6 - <12 Years of Age, MVC Liquid Formulation', 'description': 'In Cohort 3, Participants aged \\>=6 to \\<12 years, received MVC liquid formulation (20 mg/mL).'}, {'id': 'BG003', 'title': '>=12 - <18 Years of Age, MVC Tablet Formulation', 'description': 'In Cohort 4, Participants aged \\>=12 to \\<18 years, received MVC tablet formulation (25 mg, 75 mg, 150 mg).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '9.1', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '2.0', 'groupId': 'BG002'}, {'value': '14.0', 'spread': '1.6', 'groupId': 'BG003'}, {'value': '10.3', 'spread': '4.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) consisted of all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2008-11-12', 'resultsFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-28', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic(PK): Maraviroc PK Parameter, Average Plasma Concentration (Cavg), Trough Concentration(Cmin), Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)', 'description': 'Cavg: calculated as area under the curve divided by a dosing interval of 12 hours. Cmin: directly observed plasma concentration prior to the next dose. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.'}, {'measure': 'Area Under the Curve at Steady State (AUCtau)', 'timeFrame': 'Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)', 'description': 'AUCtau is the area under the plasma concentration time curve (AUC) at steady state from time zero (pre-dose) to end of dosing interval (tau), here dosing interval is 12 hours.'}, {'measure': 'Time to Reach Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)'}, {'measure': 'Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events(AEs) (All Causality)', 'timeFrame': 'Baseline up to 5 years', 'description': 'Incidence is reported in terms of number of events of AEs. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs as follows: Grade 1= Symptoms causing no or minimal interference with usual social and functional activities; Grade 2= Symptoms causing greater than minimal interference with usual social and functional activities; Grade 3= Symptoms causing inability to perform usual social and functional activities; Grade 4= Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data have been reported in the measure for Grade 3 and 4 as per system organ class and preferred term.'}, {'measure': 'Treatment Discontinuation: Secondary Reasons- Serious Adverse Event (SAE) Related to Study Drug', 'timeFrame': 'Baseline up to 5 years', 'description': 'The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE and was considered as a secondary reason.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA <400 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F) Approach', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'The proportion of participants who achieved HIV-1 RNA \\<400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration\'s (FDA\'s) Missing, Switch, Discontinuation\'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.'}, {'measure': 'Percentage of Participants With HIV-1 RNA <48 Copies/mL Through Week 48 Using Missing, Discontinuation = Failure (MD=F)Approach', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'The proportion of participants who achieved HIV-1 RNA \\<48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration\'s (FDA\'s) Missing, Switch, Discontinuation\'=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the "virology-first principle" and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \\> lower limit of quantification (LLOQ) . This referred to as \\[non-completer = failure; NC=F\\] or \\[missing, discontinuation = failure; MD=F\\].'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach', 'timeFrame': 'Week 24 and Week 48 post-treatment', 'description': 'Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels \\> lower limit of quantification (LLOQ) . This referred as \\[non-completer = failure; NC=F\\] or \\[missing, discontinuation = failure; MD=F\\].'}, {'measure': 'Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48', 'timeFrame': 'Week 48', 'description': 'TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.'}, {'measure': 'Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48', 'timeFrame': 'Baseline to Week 24, Week 48 post-treatment', 'description': 'Percentage of participants with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.'}, {'measure': 'Change From Baseline in HIV-1 RNA (Original)', 'timeFrame': 'Baseline, Week 24, Week 48 post-treatment', 'description': 'Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \\[LLOQ\\] \\<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \\>1000 copies/ml was used to determine eligibility for the study.'}, {'measure': 'Change From Baseline in HIV-1 RNA (Log10 Copies/mL)', 'timeFrame': 'Baseline, Week 24, Week 48 post-treatment', 'description': 'Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification \\[LLOQ\\] \\<48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA \\>1000 copies/ml was used to determine eligibility for the study.'}, {'measure': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48', 'timeFrame': 'Baseline, Week 24, Week 48 post-treatment', 'description': 'Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.'}, {'measure': 'Change From Baseline in Percentage (%) of CD4+ Cells at Weeks 24 and 48', 'timeFrame': 'Baseline, Week 24 and Week 48 post-treatment', 'description': 'Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.'}, {'measure': 'Number of Participants With Protocol Defined Virologic Failure', 'timeFrame': 'Week 48', 'description': 'The occurrence of any one of the following criteria would constitute Virologic failure: Criteria A=Decrease from Baseline plasma HIV-1 RNA \\<1 log10 and plasma HIV-1 RNA \\>400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; Criteria B=Decrease from Baseline plasma HIV-1 RNA \\<2.0 log10 and plasma HIV-1 RNA \\>400 copies/mL at Week 24 OR plasma HIV-1 RNA \\>10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; Criteria C=Increase from nadir plasma HIV-1 RNA of \\>=1 log10 (\\>=1,000 copies/mL if nadir plasma HIV-1 RNA \\<48 copies/mL) at any time, and confirmed within 14 to 21 days.'}, {'measure': 'Number of Participants With Viral Tropism Between Screening and Confirmed Protocol Defined Virologic Failure (PDVF) Prior to Week 48', 'timeFrame': 'Screening to Week 48', 'description': 'Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. Change in detected tropism from screening to the time of failure prior to Week 48 was reported. X4=CXCR4 tropic virus; R5=CCR5-tropic virus; X4=CXCR4-tropic virus. Number of participants as per tropism to respective virus has been reported.'}, {'measure': 'Number of Participants With Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF', 'timeFrame': '48 weeks', 'description': 'Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Data for participants with respective gene mutation category has been reported. Participants with more than one mutation are counted more than once.'}, {'measure': 'Percentage of Participants With Optimized Background Treatment Susceptibility Scores', 'timeFrame': '48 weeks', 'description': 'Data was summarized by the total ARV activity of the background regimen using simple and weighted total optimized background treatment susceptibility scores as well as by screening genotype. Simple total optimized background treatment (OBT) susceptibility scores were categorized as 0, 1, \\>=2 and weighted total OBT susceptibility scores were categorized as 0 to 0.5, 1 to 1.5 and \\>=2. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores ranged from 0 to 1 as 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance, where higher scores indicated lower resistance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open label pharmacokinetic safety and efficacy in HIV-1 infected pediatrics'], 'conditions': ['Human Immunodeficiency Virus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001031&StudyName=An%20Open%20Label%20Pharmacokinetic%2C%20Safety%20And%20Efficacy%20Study%20Of%20Maraviroc%20In%20Combination%20With%20Background%20Therapy%20For%20The%20Treatment%20Of%20HIV-', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL\n\nExclusion Criteria:\n\n* X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay\n* Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs)\n* Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and creatinine, lipase;\n* Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen includes atazanavir; ALT/AST \\< 2.5 X ULN; No symptoms other than jaundice or icterus.\n* Other laboratory values ≥Grade 3, must be reviewed by Pfizer.'}, 'identificationModule': {'nctId': 'NCT00791700', 'briefTitle': 'An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC, SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2 - <18 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'A4001031'}, 'secondaryIdInfos': [{'id': '2008-006873-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maraviroc', 'description': 'Subjects will be stratified by age and formulation into one of the following cohorts:\n\nCohort 1: ≥2-\\<6 years of age, maraviroc liquid formulation; Cohort 2: ≥6-\\<12 years of age, maraviroc tablet formulation; Cohort 3: ≥6-\\<12 years of age, maraviroc liquid formulation and Cohort 4: ≥12-\\<18 years of age, maraviroc tablet formulation.', 'interventionNames': ['Drug: Maraviroc']}], 'interventions': [{'name': 'Maraviroc', 'type': 'DRUG', 'otherNames': ['Selzentry'], 'description': "Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.", 'armGroupLabels': ['Maraviroc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. DuPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Rainbow Center at University of Florida Health', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Health System, IDP', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '39213', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Pediatric Infectious Disease Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Batson Specialty Clinic', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '45206', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Center for Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Physician', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU Health System Clinical Research Services', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '01246-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Infectologia Emilio Ribas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01416-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Condomínio Edifício Parque Paulista', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Clinica Pediatrica Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Farmacia Interna', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00165', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS Ospedale Pediatrico Bambino Gesu', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '06720', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Infantil de Mexico Federico Gomez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '8000-386', 'city': 'Faro', 'country': 'Portugal', 'facility': 'Centro Hospitalar Universitario do Algarve, EPE', 'geoPoint': {'lat': 37.01869, 'lon': -7.92716}}, {'zip': '1169-045', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Lisboa Central, EPE', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Lisboa Norte, EPE', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4202-451', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital S. João, E.P.E', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '00935', 'city': 'San Juan', 'state': 'PR', 'country': 'Puerto Rico', 'facility': 'Hospital San Juan Research Unit', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Iatros International', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '1501', 'city': 'Benoni', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Lakeview Hospital', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '0208', 'city': 'Ga-Rankuwa', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Dr George Mukhari Hospital'}, {'zip': '3000', 'city': 'Dundee', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Dr. Jan Fourie Medical Centre', 'geoPoint': {'lat': -28.16678, 'lon': 30.23371}}, {'zip': '0083', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Embassy Drive Medical Center', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '08950', 'city': 'Esplugues de Llobregat, Barcelona', 'state': 'Spain', 'country': 'Spain', 'facility': 'Hospital Sant Joan de Deu'}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '40002', 'city': 'Muang', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Department of Pediatric, Faculty of Medicine, Khon Kaen University'}, {'zip': '50200', 'city': 'Muang', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Pediatrics, Faculty of Medicine, Chiang Mai University'}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Pediatrics, Faculty of Medicine, Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}