Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT00307151
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2006-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'C558899', 'term': 'lopinavir-ritonavir drug combination'}, {'id': 'D019829', 'term': 'Nevirapine'}, {'id': 'D015215', 'term': 'Zidovudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D013936', 'term': 'Thymidine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mallen@fhi360.org', 'phone': '(919) 405-1429', 'title': 'Melissa Allen, Director, IMPAACT Operations Center', 'organization': 'Family Health International (FHI 360)'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscript and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Accrual to Cohort I was terminated early by the Data Safety Monitoring Committee after enrollment of 164 of the planned 288 subjects.'}}, 'adverseEventsModule': {'timeFrame': 'From study enrollment until study completion', 'description': 'Expedited adverse event (AE) reporting followed Intensive Division of AIDS (DAIDS) Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities requiring hospitalization and \\>=grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs", V1.0, 12/2004.', 'eventGroups': [{'id': 'EG000', 'title': 'Coh I: NVP', 'description': 'Cohort II: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 81, 'seriousNumAtRisk': 82, 'deathsNumAffected': 6, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort II: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 82, 'seriousNumAtRisk': 82, 'deathsNumAffected': 3, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 146, 'seriousNumAtRisk': 147, 'deathsNumAffected': 10, 'seriousNumAffected': 65}, {'id': 'EG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 140, 'seriousNumAtRisk': 140, 'deathsNumAffected': 6, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 20}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 68}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 42}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Persistent generalised lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Plasmodium falciparum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Purulent discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tinea faciei', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tinea infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 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'EG003', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutrophil count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypocalcaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breath holding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '40.8', 'groupId': 'OG002'}, {'value': '19.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.6', 'ciLowerLimit': '3.7', 'ciUpperLimit': '33.6', 'pValueComment': 'P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.', 'estimateComment': 'Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Risk difference estimate stratified by age (\\<12 months vs. \\>=12 months)and reports rate on NVP arm minus rate on LPV/r arm'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.5', 'ciLowerLimit': '11.2', 'ciUpperLimit': '31.8', 'pValueComment': 'P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.', 'estimateComment': 'Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Risk difference estimate stratified by age (\\<12 months vs. \\>=12 months) and reports rate on NVP arm minus rate on LPV/r arm'}], 'paramType': 'NUMBER', 'timeFrame': 'Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'title': '10th percentile', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '24'}]}]}, {'title': '25th percentile', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '36', 'comment': 'Not estimable as upper limit for survival function at all weeks is above 75%', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': 'NA'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '36', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '108'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR a confirmed viral rebound \\>4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Experiencing Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '12.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '16'}, {'value': '16', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '24'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '24', 'comment': 'Not estimable as upper limit for survival function at all weeks above 90%', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': 'NA'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '24', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '36'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR a confirmed viral rebound \\>4000 copies/mL after week 24 OR death.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population'}, {'type': 'SECONDARY', 'title': 'Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'title': '10th percentile', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '25'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': '25th percentile', 'categories': [{'measurements': [{'value': '24', 'comment': 'Not estimable as upper limit for survival function at all weeks above 75%', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': 'NA'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '86'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '7', 'upperLimit': '24'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Uses follow-up from start of NVP or LPV/r component of study treatment until component switched or date of DSMB decision to unblind results, whichever occurred first'}, {'type': 'SECONDARY', 'title': 'Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results included for any participant who was a virologic failure as defined in secondary outcome 4 and who had results available at study entry and virologic failure.'}, {'type': 'SECONDARY', 'title': 'Change in CD4 Percent From Entry to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '16.2'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '13.7'}, {'value': '15.2', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '16.9'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '15.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.', 'unitOfMeasure': 'Percent of CD4', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population. Change reported if subject followed at least 48 weeks before DSMB unblinding of results for each Cohort'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to HIV-related Disease Progression or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '35', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '132'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': '17', 'comment': 'Not estimable as upper limit of survival function at all weeks above 90%', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': 'NA'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '24'}, {'value': '35', 'comment': 'Not estimable as upper limit of survival function at all weeks above 98%', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': 'NA'}, {'value': '132', 'comment': 'Not estimable as upper limit of survival function at all weeks above 98%', 'groupId': 'OG003', 'lowerLimit': '35', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'OG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'OG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'OG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '68'}, {'value': '3', 'comment': 'Not estimable as upper limit for survival function at all weeks above 98%', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': 'NA'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '83', 'comment': 'Not estimable as upper limit for survival function at all weeks above 98%', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Results report 2nd percentile of time from randomization to death', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis uses intent to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'FG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'FG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'FG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'comment': 'One participant never started treatment, were not followed and not included in analysis.', 'groupId': 'FG003', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Results are through date DSMB closed Cohort I to accrual (April 20, 2009)', 'groupId': 'FG000', 'numSubjects': '71'}, {'comment': 'Results are through date DSMB closed Cohort I to accrual (April 20, 2009)', 'groupId': 'FG001', 'numSubjects': '75'}, {'comment': 'Results are through date DSMB recommended Cohort II results be unblinded (October 27, 2010)', 'groupId': 'FG002', 'numSubjects': '127'}, {'comment': 'Results are through date DSMB recommended Cohort II results be unblinded (October 27, 2010)', 'groupId': 'FG003', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Severe debilitation, unable to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject unable to get to clinic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Not willing to adhere to study reqs', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Clinic unable to contact subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study participants were recruited at 10 study sites, 4 in South Africa and 1 each in Uganda, Zimbabwe, Zambia, Malawi, Tanzania and India between November 9, 2006 and March 19, 2010.', 'preAssignmentDetails': 'Infants and children 6 - 36 months of age (lower age limit changed to 2 months in Protocol Version 4.0) were stratified by age (2-\\<6 months, 6-\\<12 months and \\>=12 months) and randomly assigned to receive either AZT/3TC/NVP or AZT/3TC/LPV/r. One subject was randomized but never started study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}, {'value': '451', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.'}, {'id': 'BG001', 'title': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.'}, {'id': 'BG002', 'title': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen'}, {'id': 'BG003', 'title': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<12 months', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '200', 'groupId': 'BG004'}]}]}, {'title': '>=12 months', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '251', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '237', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '214', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black African', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '428', 'groupId': 'BG004'}]}]}, {'title': 'Coloured', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Native of India', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Not available', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tanzania', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Zambia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}, {'title': 'Uganda', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': 'Malawi', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '213', 'groupId': 'BG004'}]}]}, {'title': 'Zimbabwe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ever breastfed', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Documentation of SD NVP use at birth', 'classes': [{'title': 'Born before NVP available/mother known to have HIV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}]}]}, {'title': 'Medical record review', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}]}, {'title': 'Verbal evidence only', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}, {'title': 'Found to have received SD NVP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'WHO Stage', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '234', 'groupId': 'BG004'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'World Health Organization (WHO) staging system for HIV infection and disease.', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA', 'classes': [{'title': '<100,000 copies/ml', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}, {'title': '100,000 - < 750,000 copies/ml', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}]}, {'title': '>=750,000 copies/ml', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '209', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Percent', 'classes': [{'title': '<15 Percent', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}]}]}, {'title': '15 Percent - < 25 Percent', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}]}]}, {'title': '>= 25 Percent', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NVP resistance', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '331', 'groupId': 'BG004'}]}]}, {'title': 'Not available', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-15', 'studyFirstSubmitDate': '2006-03-24', 'resultsFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2006-03-24', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-05', 'studyFirstPostDateStruct': {'date': '2006-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants With Treatment Failure, Defined as a Confirmed Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment', 'timeFrame': 'Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR permanent discontinuation of the randomized NNRTI or PI component of study treatment at or prior to 24 weeks of treatment for any reason including death. Results report percent of participants reaching a treatment failure endpoint by week 24 calculated using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Time From Randomization to Treatment Failure, Defined as Virologic Failure or Permanent Discontinuation of the Randomized NNRTI or PI Component of Study Treatment', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Treatment failure is defined as a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR a confirmed viral rebound \\>4000 copies/mL after week 24 OR permanent discontinuation of the randomized NNRTI or PI component of study treatment for any reason including death.'}, {'measure': 'Percent of Participants Experiencing Virologic Failure', 'timeFrame': 'Earlier of 24 weeks or date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Virologic failure is defined as a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR death on or before 24 weeks. Results report percent of participants reaching a virologic failure endpoint by week 24 calculated using the Kaplan-Meier method.'}, {'measure': 'Time From Randomization to Virologic Failure', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Virologic failure is defined as the earlier of a confirmed plasma HIV-1 RNA level that is \\<1 log10 copies/mL below the study entry value at 12 to 24 weeks after treatment is initiated OR a confirmed plasma HIV-1 RNA level \\>400 copies/mL at 24 weeks OR a confirmed viral rebound \\>4000 copies/mL after week 24 OR death.'}, {'measure': 'Time From Start of Study Treatment to First New Grade >=3 Lab Abnormality, Sign or Symptom Occurring on Study Treatment', 'timeFrame': 'On randomized NNRTI or PI component of study treatment and until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Safety events include lab abnormalities, signs or symptoms of grade 3 or higher. Events were graded according to the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events, Version 1.0. Events defined as new if first occurrence was after initiation of study treatment or if severity increased from entry and while on the NNRTI or PI component of study treatment.'}, {'measure': 'Number of Participants Developing New NRTI, NNRTI or PI-resistant Virus', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Numbers of participants developing new NRTI, NNRTI or PI-resistant virus after reaching a virologic failure endpoint'}, {'measure': 'Change in CD4 Percent From Entry to Week 48', 'timeFrame': '48 weeks if before date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009; Coh II: October 27, 2010)', 'description': 'Change was calculated as CD4 percent at week 48 minus entry CD4 percent (last CD4 percent before randomization date). Only subjects who reached 48 weeks of follow-up before DSMB decisions to unblind each Cohort were included in summary.'}, {'measure': 'Time From Randomization to HIV-related Disease Progression or Death', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'HIV-related disease progression was defined as progression in WHO clinical stage from stage at entry or death. For subjects in WHO Stage IV at entry, disease progression was defined as death.'}, {'measure': 'Time From Randomization to Death', 'timeFrame': 'Until date of DSMB decision to unblind Cohort results (Coh I: April 20, 2009 - median follow-up 48 weeks and range 0 - 125 weeks; Coh II: October 27, 2010 - median follow-up 72 weeks and range from 0 to 204 weeks)', 'description': 'Results report 2nd percentile of time from randomization to death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Naive', 'Mother-To-Child Transmission', 'MTCT', 'Pediatrics', 'Viral resistance'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17533166', 'type': 'BACKGROUND', 'citation': 'Arrive E, Newell ML, Ekouevi DK, Chaix ML, Thiebaut R, Masquelier B, Leroy V, Perre PV, Rouzioux C, Dabis F; Ghent Group on HIV in Women and Children. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int J Epidemiol. 2007 Oct;36(5):1009-21. doi: 10.1093/ije/dym104. Epub 2007 May 28.'}, {'pmid': '17457089', 'type': 'BACKGROUND', 'citation': 'Chi BH, Sinkala M, Stringer EM, Cantrell RA, Mtonga V, Bulterys M, Zulu I, Kankasa C, Wilfert C, Weidle PJ, Vermund SH, Stringer JS. Early clinical and immune response to NNRTI-based antiretroviral therapy among women with prior exposure to single-dose nevirapine. AIDS. 2007 May 11;21(8):957-64. doi: 10.1097/QAD.0b013e32810996b2.'}, {'pmid': '16425125', 'type': 'BACKGROUND', 'citation': 'Eshleman SH, Hoover DR, Hudelson SE, Chen S, Fiscus SA, Piwowar-Manning E, Jackson JB, Kumwenda NI, Taha TE. Development of nevirapine resistance in infants is reduced by use of infant-only single-dose nevirapine plus zidovudine postexposure prophylaxis for the prevention of mother-to-child transmission of HIV-1. J Infect Dis. 2006 Feb 15;193(4):479-81. doi: 10.1086/499967. Epub 2006 Jan 11.'}, {'pmid': '17538875', 'type': 'BACKGROUND', 'citation': 'White PD. What causes prolonged fatigue after infectious mononucleosis: and does it tell us anything about chronic fatigue syndrome? J Infect Dis. 2007 Jul 1;196(1):4-5. doi: 10.1086/518615. Epub 2007 May 24. No abstract available.'}, {'pmid': '17538878', 'type': 'BACKGROUND', 'citation': 'Sankatsing RR, Wit FW, Pakker N, Vyankandondera J, Mmiro F, Okong P, Kastelein JJ, Lange JM, Stroes ES, Reiss P. Effects of nevirapine, compared with lamivudine, on lipids and lipoproteins in HIV-1-uninfected newborns: the stopping infection from mother-to-child via breast-feeding in Africa lipid substudy. J Infect Dis. 2007 Jul 1;196(1):15-22. doi: 10.1086/518248. Epub 2007 May 16.'}, {'pmid': '20942667', 'type': 'RESULT', 'citation': 'Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1510-20. doi: 10.1056/NEJMoa1000931.'}, {'type': 'RESULT', 'citation': 'Palumbo P, Violari A, Lindsey J, Hughes M, Jean-Philippe P, Mofenson L, Purdue L, Eshleman S for the IMPAACT P1060 Study Team. Nevirapine vs Lopinavir-ritonavir-based antiretroviral therapy in single dose Nevirapine-exposed HIV-infected infants: preliminary results from the IMPAACT P1060 Trial. 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Capetown, July, 2009.'}, {'type': 'RESULT', 'citation': 'Palumbo P, Violari A, Lindsey J, Hughes M, Jean-Philippe P, Mofenson L, Bwakura-Dangarembizi M, Kamthunzi P, Eshleman S and Prudue L for the IMPAACT P1060 Team. Nevirapine (NVP)-vs. Lopinavir-Ritonavir (LPV/r)-based antiretroviral therapy (ART) among HIV-infected infants in resource-limited settings: The IMPAACT P1060 Trial. 18th Conference on Retroviruses and Opportunistic Infections, Boston, February, 2011.'}, {'pmid': '30102656', 'type': 'DERIVED', 'citation': 'Patel K, Lindsey J, Angelidou K, Aldrovandi G, Palumbo P; IMPAACT P1060 Study Team. Metabolic effects of initiating lopinavir/ritonavir-based regimens among young children. AIDS. 2018 Oct 23;32(16):2327-2336. doi: 10.1097/QAD.0000000000001980.'}, {'pmid': '29189677', 'type': 'DERIVED', 'citation': 'Angelidou K, Palumbo P, Lindsey J, Violary A, Archary M, Barlow L, Claggett B, Hughes M, Wei LJ; International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) P1060 Study Team. Defining Study Outcomes That Better Reflect Individual Response to Treatment. Pediatr Infect Dis J. 2018 Mar;37(3):258-262. doi: 10.1097/INF.0000000000001766.'}, {'pmid': '27439527', 'type': 'DERIVED', 'citation': 'Barlow-Mosha L, Angelidou K, Lindsey J, Archary M, Cotton M, Dittmer S, Fairlie L, Kabugho E, Kamthunzi P, Kinikar A, Mbengeranwa T, Msuya L, Sambo P, Patel K, Barr E, Jean-Phillipe P, Violari A, Mofenson L, Palumbo P, Chi BH. Nevirapine- Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy in HIV-Infected Infants and Young Children: Long-term Follow-up of the IMPAACT P1060 Randomized Trial. Clin Infect Dis. 2016 Oct 15;63(8):1113-1121. doi: 10.1093/cid/ciw488. Epub 2016 Jul 20.'}, {'pmid': '25222305', 'type': 'DERIVED', 'citation': 'Lindsey JC, Hughes MD, Violari A, Eshleman SH, Abrams EJ, Bwakura-Dangarembizi M, Barlow-Mosha L, Kamthunzi P, Sambo PM, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Zimmer B, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P; P1060 Study Team. Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission. Pediatr Infect Dis J. 2014 Aug;33(8):846-54. doi: 10.1097/INF.0000000000000337.'}, {'pmid': '22716976', 'type': 'DERIVED', 'citation': 'Violari A, Lindsey JC, Hughes MD, Mujuru HA, Barlow-Mosha L, Kamthunzi P, Chi BH, Cotton MF, Moultrie H, Khadse S, Schimana W, Bobat R, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Palumbo P. Nevirapine versus ritonavir-boosted lopinavir for HIV-infected children. N Engl J Med. 2012 Jun 21;366(25):2380-9. doi: 10.1056/NEJMoa1113249.'}]}, 'descriptionModule': {'briefSummary': 'A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV. The purpose of this study was to compare the effectiveness of a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based antiretroviral regimen versus a protease inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP for prevention of MTCT.\n\n\\>\\>\n\n\\>\\> A five year follow up has been added to the study.', 'detailedDescription': 'Single dose nevirapine (SD NVP) has greatly reduced the rate of mother-to-child transmission (MTCT) of HIV. Non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens are recommended for use by the World Health Organization (WHO) in resource-limited settings. However, research suggests that mothers and infants exposed to SD NVP experience higher virologic failure rates when treated with NNRTI-based regimens than their unexposed counterparts. Data show that the use of SD NVP is associated with NNRTI resistance in HIV infected women and infants. The purpose of this trial was to compare and evaluate virologic responses to an NNRTI-based regimen versus a protease-inhibitor (PI)-based regimen in HIV infected infants who had or had not been exposed to SD NVP intrapartum and after birth.\n\n\\>\\>\n\n\\>\\> Participants were enrolled into one of two Cohorts with proposed enrollment into each Cohort of 288 participants. Cohort I participants must have received SD NVP for prevention of MTCT. Cohort II participants and their mothers must not have previously received NVP or any other NNRTIs. Participants in both Cohorts were randomly assigned to receive either an NNRTI (Coh I:NVP and Coh II: NVP) or PI (Coh I: LPV/r and Coh II: LPV/r) -based regimen. The NNRTI-based regimen included NVP, zidovudine (ZDV) and lamivudine (3TC). The PI-based regimen included lopinavir/ritonavir (LPV/r), ZDV and 3TC. If participants experienced adverse reactions to ZDV, stavudine (d4T) could be substituted. Randomization was stratified by age (6-\\<12 months vs. \\>=12 months, with the 2-\\<6 month stratum added in protocol version 4.0 when the lower age limit was decreased from 6 months to 2 months).\n\n\\>\\>\n\n\\>\\> Study visits were scheduled at entry, weeks 2, 4, 8, 12, 16, 24 and then every 24 weeks. A physical exam, blood collection, and assessments of HIV-related symptoms occurred at all visits.\n\n\\>\\>\n\n\\>\\> Based on a Data Safety and Monitoring Committee (DSMB) review of study data on April 20 2009, enrollment to Cohort I was closed and interim results released. Data from this and another similar study (AIDS Clinical Trials Group (ACTG) A5208) conducted in mothers, showed that the PI-based regimen was more effective than the NNRTI-based regimen in infants who had received SD NVP for prevention of MTCT. Cohort II was allowed to remain open for enrollment and the lower age limit for enrollment reduced from 6 months to 2 months.\n\n\\>\\>\n\n\\>\\> In June 2010, follow-up for all subjects was extended from the original 24 weeks beyond enrollment of the last subject to 48 weeks. On October 27 2010, the DSMB conducted a final review of Cohort II data, and recommended results be unblinded and released. As found in Cohort I, the PI-based regimen was more effective than the NNRTI-based regimen in infants who had not been previously exposed to SD NVP for PMTCT. Primary and secondary outcome results for Cohort I include all follow-up until April 20, 2009 and for Cohort II, all follow-up until October 27, 2010.\n\n\\>\\>\n\n\\>\\> Version 5.0 of the protocol (March 21, 2011) extended follow-up on all subjects for an additional 5 years to December 2016. The purpose of the extension was to collect long term safety and virologic efficacy data in this study population and to pilot administration of a series of neuropsychological tests. During the extension, participants did not receive any medications through the study, but instead through their local clinics. Clinic visits took place every 3 months. Adverse event summaries use all follow-up in both Cohorts until December, 2016.\n\n\\>\\>\n\n\\>\\>'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for All Participants:\\>\\>\n\n* age \\>=6 months to \\< 36 months (decreased to 2 months in protocol version 4.0)\\>\\>\n* HIV infected\\>\\>\n* Viral load greater than 5,000 copies/ml within 60 days of study entry\\>\\>\n* Treatment naive except for antiretrovirals (ARV) used to prevent MTCT (infant ARV use for \\<=1 week postpartum for prevention of MTCT allowed) \\>\\>\n* Eligible for treatment according to WHO pediatric algorithm (updated in protocol version 1.0, Letter of amendment (LOA)#1) and protocol version 2.0, LOA#3). Subjects with active opportunistic infections were not eligible for study participation until they had been treated and were clinically stable \\>\\>\n* Parent or legal guardian willing to provide signed informed consent\\>\\>\n\nInclusion Criteria for Cohort I:\\>\\>\n\n* Documentation of maternal or infant NVP exposure or a highly reliable verbal report. (Updated in protocol version 2.0, LOA#3 to require written clinic/hospital documentation of infant exposure to SD NVP)\\>\\>\n* Use of maternal ARV, including NVP, permitted during pregnancy\\>\\>\n* One or more of the following: strict formula feeding, initial infant HIV diagnosis occurring while younger than 60 days of age, or an initial AIDS-defining illness diagnosis by WHO criteria while younger than 60 days of age. \\>\\>\n\nInclusion Criteria for Cohort II:\\>\\>\n\n* Use of maternal ARVs, excluding NNRTIs, permitted during pregnancy\\>\\>\n* Evidence of lack of prior NVP exposure (added in protocol version 2.0, LOA#3) by review of maternal and child medical records or health card (or other written documentation) for evidence of NVP exposure to mother or infant during pregnancy, labor, and delivery. If no written documentation showing lack of NVP use was shown in these records or if these records were not available for review, then a verbal report considered to be highly reliable by the study nurse was acceptable AND one or more of the following: \\>\\>\n\n 1. Study subject born before single dose NVP was available for prevention of MTCT of HIV in the location of birth of study subject\\>\\>\n 2. Study subject born before the biological mother's first positive HIV test\\>\\>\n 3. Site staff had another reason to believe the subject had not been exposed to NVP \\>\\> \\>\\> Exclusion Criteria for All Participants:\\>\\>\n* Grade 2 or higher aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at study screening\\>\\>\n* Grade 3 or higher laboratory toxicity at study screening\\>\\>\n* Received ARVs for anything other than the prevention of intrapartum MTCT. Infants who received ARVs after the first week of life (e.g., for the prevention of MTCT of HIV through breastfeeding) were excluded \\>\\>\n* Acute serious infections requiring active treatment. Subjects could be receiving treatment for active TB if it did not include rifamycin drugs\\>\\>\n* Receiving chemotherapy for an active tumor\\>\\>\n* History of a cardiac conduction abnormality and underlying structural heart disease\\>\\>\n* Required certain medications\\>\\> \\>\\> Exclusion Criteria for Cohort I: \\>\\>\n* History of or currently breastfeeding. Breastfed infants with a positive HIV test or who had experienced an AIDS-defining illness by WHO criteria at 60 days of age or younger were not excluded\\>\\>\n\nExclusion Criteria for Cohort II:\\>\\>\n\n* Exposure to any maternal NVP or other NNRTI prior to or during the pregnancy or while breastfeeding\\>\\>\n* Exposure of infant to NVP at any time including during the first week of life"}, 'identificationModule': {'nctId': 'NCT00307151', 'acronym': 'P1060', 'briefTitle': 'Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV', 'organization': {'class': 'NETWORK', 'fullName': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group'}, 'officialTitle': 'Phase II, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission', 'orgStudyIdInfo': {'id': 'IMPAACT P1060'}, 'secondaryIdInfos': [{'id': 'U01AI068632', 'link': 'https://reporter.nih.gov/quickSearch/U01AI068632', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coh I: NVP', 'description': 'Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.', 'interventionNames': ['Drug: Lamivudine', 'Drug: Nevirapine', 'Drug: Zidovudine']}, {'type': 'EXPERIMENTAL', 'label': 'Coh I: LPV/r', 'description': 'Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.', 'interventionNames': ['Drug: Lamivudine', 'Drug: Lopinavir/ritonavir', 'Drug: Zidovudine']}, {'type': 'EXPERIMENTAL', 'label': 'Coh II: NVP', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen', 'interventionNames': ['Drug: Lamivudine', 'Drug: Nevirapine', 'Drug: Zidovudine']}, {'type': 'EXPERIMENTAL', 'label': 'Coh II: LPV/r', 'description': 'Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen', 'interventionNames': ['Drug: Lamivudine', 'Drug: Lopinavir/ritonavir', 'Drug: Zidovudine']}], 'interventions': [{'name': 'Lamivudine', 'type': 'DRUG', 'otherNames': ['3TC', 'Epivir'], 'description': '4 mg/kg twice daily', 'armGroupLabels': ['Coh I: LPV/r', 'Coh I: NVP', 'Coh II: LPV/r', 'Coh II: NVP']}, {'name': 'Lopinavir/ritonavir', 'type': 'DRUG', 'otherNames': ['LPV/r', 'Kaletra', 'LPV/RTV'], 'description': '16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg', 'armGroupLabels': ['Coh I: LPV/r', 'Coh II: LPV/r']}, {'name': 'Nevirapine', 'type': 'DRUG', 'otherNames': ['NVP', 'Viramune'], 'description': 'Initially: 4 mg/kg for 14 days, then 7 mg/kg twice daily. In protocol version 2.0, Letter of Amendment 1 (September 2007), NVP dose increased to conform with WHO guidelines to: 160 to 200 mg/m\\^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m\\^2/dose to max 200 mg twice daily', 'armGroupLabels': ['Coh I: NVP', 'Coh II: NVP']}, {'name': 'Zidovudine', 'type': 'DRUG', 'otherNames': ['ZDV', 'AZT', 'Retrovir'], 'description': '180 mg/m\\^2 twice daily', 'armGroupLabels': ['Coh I: LPV/r', 'Coh I: NVP', 'Coh II: LPV/r', 'Coh II: NVP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'BJ Medical College CRS', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Mzimba Road', 'state': 'Lilongwe', 'country': 'Malawi', 'facility': 'University of North Carolina Lilongwe CRS'}, {'zip': '50202', 'city': 'Natal', 'state': 'Durban', 'country': 'South Africa', 'facility': 'Nelson R. Mandela School of Medicine, University of Kwazulu'}, {'zip': '7700', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'University of Stellenbosch-Tygerberg Hospital, South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '2013', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Harriet Shezi Clinic at Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'IDC Research Offices', 'state': 'Moshi', 'country': 'Tanzania', 'facility': 'Kilimanjaro Christian Medical CRS'}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Makerere University', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Lusaka', 'country': 'Zambia', 'facility': 'George Clinic CRS', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'UZ-College of Health Sciences', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Paul Palumbo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Infectious Diseases and International Health, Dartmouth-Hitchcock Medical Center'}, {'name': 'Avy Violari, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Perinatal HIV Research Unit, University of Witwatersrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}