Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT00089505
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2004-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'D019829', 'term': 'Nevirapine'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'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': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG ClinicalTrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, '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 manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms (with median follow-up: 72 weeks; range 0 -144 weeks). Throughout study for NoNVP/NVP and NoNVP/LPV_r arms (median follow-up: 72 weeks; range 0-180 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.', 'otherNumAtRisk': 121, 'otherNumAffected': 110, 'seriousNumAtRisk': 121, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.', 'otherNumAtRisk': 120, 'otherNumAffected': 105, 'seriousNumAtRisk': 120, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.', 'otherNumAtRisk': 249, 'otherNumAffected': 225, 'seriousNumAtRisk': 249, 'seriousNumAffected': 26}, {'id': 'EG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.', 'otherNumAtRisk': 251, 'otherNumAffected': 227, 'seriousNumAtRisk': 251, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 251, 'numEvents': 251, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 251, 'numEvents': 251, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vulvovaginal cadidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blookd albumin abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood bicarbonate abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood cholesterol abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 58}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 40}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Low density lipoprotein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 64}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 249, 'numEvents': 249, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 24}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 17}, {'groupId': 'EG001', 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'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Steve-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Virologic Failure or Died.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.', 'description': 'Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Who Experienced Virologic Failure or Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'title': 'week 48 percent of virologic failure or death', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '31'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '19'}, {'value': '14', 'groupId': 'OG003', 'lowerLimit': '9', 'upperLimit': '18'}]}]}, {'title': 'week 96 percent of virologic failure or death', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '40'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '21'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.', 'description': 'Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.', 'unitOfMeasure': 'Percent of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).'}, {'type': 'SECONDARY', 'title': 'CD4 Count Change From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'title': 'Week 48 CD4 count change from randomization', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '270'}, {'value': '201', 'groupId': 'OG001', 'lowerLimit': '142', 'upperLimit': '280'}, {'value': '172', 'groupId': 'OG002', 'lowerLimit': '97', 'upperLimit': '246'}, {'value': '172', 'groupId': 'OG003', 'lowerLimit': '97', 'upperLimit': '268'}]}]}, {'title': 'Week 96 CD4 count change from randomization', 'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000', 'lowerLimit': '189', 'upperLimit': '366'}, {'value': '278', 'groupId': 'OG001', 'lowerLimit': '180', 'upperLimit': '360'}, {'value': '223', 'groupId': 'OG002', 'lowerLimit': '142', 'upperLimit': '339'}, {'value': '256', 'groupId': 'OG003', 'lowerLimit': '149', 'upperLimit': '379'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.', 'description': 'Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV\\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\\_r arms, since the follow-up continued as planned, data through overall study were used.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes were calculated using the intent-to-treat approach (i.e. ignoring changes from randomized treatment) but no imputation was done for missing values.', 'anticipatedPostingDate': '2010-08'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.17'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.18'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.', 'description': 'The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV\\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\\_r arms, since the follow-up continued as planned, data through overall study were used.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use as-treated method.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced HIV-related Disease Progression or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.09'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.07'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.11'}, {'value': '26', 'groupId': 'OG003', 'lowerLimit': '0.05', 'upperLimit': '0.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.', 'description': 'Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).'}, {'type': 'PRIMARY', 'title': 'Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '84'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '84', 'comment': 'Not estimable as the upper limit for survival function at all weeks is above 90%', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': 'NA'}]}]}, {'title': '25th percentile', 'categories': [{'measurements': [{'value': '60', 'comment': 'Not estimable as the upper limit for survival function at all weeks is above 75%', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as the estimates for survival function at all weeks is above 75%', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.69', 'ciLowerLimit': '1.79', 'ciUpperLimit': '7.61', 'pValueComment': 'P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.', 'estimateComment': 'The HR is for NVP/NVP vs. NVP/LPV\\_r.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model was stratified by screening CD4 strata (\\<50 vs. \\>=50 cells/mm\\^3).'}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.', 'description': '5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).'}, {'type': 'PRIMARY', 'title': 'Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'title': '5th percentile', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG002', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '24'}]}]}, {'title': '10th percentile', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG002', 'lowerLimit': '24', 'upperLimit': '48'}, {'value': '36', 'groupId': 'OG003', 'lowerLimit': '12', 'upperLimit': '60'}]}]}, {'title': '25th percentile', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable as the estimate for survival function at all weeks is above 75%', 'groupId': 'OG002', 'lowerLimit': '120', 'upperLimit': 'NA'}, {'value': '132', 'comment': 'Not estimable as the upper limit for survival function at all weeks is above 75%', 'groupId': 'OG003', 'lowerLimit': '96', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.29', 'pValueComment': 'P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.', 'estimateComment': 'The HR is for NoNVP/NVP vs. NoNVP/LPV\\_r.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The cox proportional hazard model was stratified by screening CD4 strata (\\<50 vs. \\>=50 cells/mm3).', 'nonInferiorityComment': 'NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV\\_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.'}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.', 'description': '5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was intent to treat per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.', 'description': 'Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)\\>=2.6 x ULN or alanine aminotransferase (ALT)\\>=2.6 x ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the as-treated approach.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '251', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'OG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'OG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'OG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'classes': [{'title': 'week 48 percent of full adherence in past month', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}]}, {'title': 'week 96 percent of full adherence in past month', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.', 'description': 'Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV\\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\\_r arms, since the follow-up continued as planned, data through overall study were used.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use as-treated approach.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'FG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'FG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'FG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 women never started treatment and per protocol, were not followed and not included in analysis.', 'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'comment': '2 women never started treatment and per protocol, were not followed and not included in analysis.', 'groupId': 'FG002', 'numSubjects': '249'}, {'groupId': 'FG003', 'numSubjects': '251'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The results for NVP/NVP were through database cutoff for DSMB review (by 6 October 2008).', 'groupId': 'FG000', 'numSubjects': '112'}, {'comment': 'The results for NVP/LPV\\_r were through database cutoff for DSMB review (by 6 October 2008).', 'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '228'}, {'groupId': 'FG003', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were recruited at 10 sites from 7 African countries: 3 from South Africa, 2 from Kenya, and 1 each in Botswana, Malawi, Uganda, Zambia and Zimbabwe, between November 2006 to July 2008. The Botswana site enrolled participants from two locations.', 'preAssignmentDetails': 'HIV-infected, treatment-naive women, at least 13 years of age with CD4+ count\\<200 cells/mm\\^3. Four participants were randomized but did not start treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}, {'value': '741', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'NVP/NVP', 'description': 'For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.'}, {'id': 'BG001', 'title': 'NVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.'}, {'id': 'BG002', 'title': 'NoNVP/NVP', 'description': 'For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.'}, {'id': 'BG003', 'title': 'NoNVP/LPV_r', 'description': 'For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'spread': '5', 'groupId': 'BG000'}, {'value': '31', 'spread': '5', 'groupId': 'BG001'}, {'value': '35', 'spread': '7', 'groupId': 'BG002'}, {'value': '35', 'spread': '8', 'groupId': 'BG003'}, {'value': '33', 'spread': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 13 and 19 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Between 20 and 29 years', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}]}, {'title': 'Between 30 and 39 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '370', 'groupId': 'BG004'}]}]}, {'title': 'Between 40 and 49 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}]}, {'title': '>=50 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}, {'value': '741', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}, {'title': 'Zambia', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}, {'title': 'Botswana', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}]}, {'title': 'Uganda', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': 'Malawi', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '207', 'groupId': 'BG004'}]}]}, {'title': 'Zimbabwe', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 count Categorical', 'classes': [{'title': '<50 cells/mm^3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}, {'title': 'Between 50 to 99 cells/mm^3', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '157', 'groupId': 'BG004'}]}]}, {'title': 'Between 100 to 149 cells/mm^3', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '216', 'groupId': 'BG004'}]}]}, {'title': 'Between 150 to 199 cells/mm^3', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}]}, {'title': 'Between 200 to 249 cells/mm^3', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}]}]}, {'title': 'Between 250 to 299 cells/mm^3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Between 300 to 349 cells/mm^3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': '>=350 cells/mm^3', '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': 'CD4 count Continuous', 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '60', 'groupId': 'BG000'}, {'value': '135', 'spread': '61', 'groupId': 'BG001'}, {'value': '126', 'spread': '68', 'groupId': 'BG002'}, {'value': '125', 'spread': '71', 'groupId': 'BG003'}, {'value': '129', 'spread': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cell/mm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HIV-1 RNA Categorial', 'classes': [{'title': 'Between 400 and 999 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Between 1000 and 9,999 copies/mL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'Between 10,000 and 99,999 copies/mL', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '246', 'groupId': 'BG004'}]}]}, {'title': 'Between 100,000 and 749,999 copies/mL', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}, {'value': '375', 'groupId': 'BG004'}]}]}, {'title': '>=750,000 copies/mL', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'BG000', 'lowerLimit': '4.3', 'upperLimit': '5.8'}, {'value': '5.1', 'groupId': 'BG001', 'lowerLimit': '4.2', 'upperLimit': '5.9'}, {'value': '5.2', 'groupId': 'BG002', 'lowerLimit': '4.2', 'upperLimit': '5.9'}, {'value': '5.2', 'groupId': 'BG003', 'lowerLimit': '4.3', 'upperLimit': '5.8'}, {'value': '5.2', 'groupId': 'BG004', 'lowerLimit': '4.7', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'log 10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'WHO stage', 'classes': [{'title': 'Clinical stage I', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '290', 'groupId': 'BG004'}]}]}, {'title': 'Clinical stage II', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '219', 'groupId': 'BG004'}]}]}, {'title': 'Clinical stage III', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}]}]}, {'title': 'Clinical stage IV', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'World Health Organization (WHO) produced WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents. It is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 745}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-11', 'studyFirstSubmitDate': '2004-08-05', 'resultsFirstSubmitDate': '2010-08-30', 'studyFirstSubmitQcDate': '2004-08-05', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-01-07', 'studyFirstPostDateStruct': {'date': '2004-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.', 'description': '5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.'}, {'measure': 'Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry', 'timeFrame': 'Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.', 'description': '5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced Virologic Failure or Died.', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.', 'description': 'Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.'}, {'measure': 'Percent of Participants Who Experienced Virologic Failure or Died', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.', 'description': 'Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is \\>=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.'}, {'measure': 'CD4 Count Change From Randomization', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.', 'description': 'Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV\\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\\_r arms, since the follow-up continued as planned, data through overall study were used.'}, {'measure': 'Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.', 'description': 'The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV\\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\\_r arms, since the follow-up continued as planned, data through overall study were used.'}, {'measure': 'Number of Participants Who Experienced HIV-related Disease Progression or Death', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.', 'description': 'Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html'}, {'measure': 'Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.', 'description': 'Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)\\>=2.6 x ULN or alanine aminotransferase (ALT)\\>=2.6 x ULN.'}, {'measure': 'Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month', 'timeFrame': 'Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.', 'description': 'Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV\\_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV\\_r arms, since the follow-up continued as planned, data through overall study were used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Experienced', 'Treatment Naive', 'MTCT', 'HIV Seronegativity'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '12152519', 'type': 'BACKGROUND', 'citation': 'Eshleman SH, Jackson JB. Nevirapine resistance after single dose prophylaxis. AIDS Rev. 2002 Apr-Jun;4(2):59-63.'}, {'pmid': '11600822', 'type': 'BACKGROUND', 'citation': 'Eshleman SH, Mracna M, Guay LA, Deseyve M, Cunningham S, Mirochnick M, Musoke P, Fleming T, Glenn Fowler M, Mofenson LM, Mmiro F, Jackson JB. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS. 2001 Oct 19;15(15):1951-7. doi: 10.1097/00002030-200110190-00006.'}, {'pmid': '14562858', 'type': 'BACKGROUND', 'citation': 'Harris M. Efficacy and durability of nevirapine in antiretroviral-experienced patients. J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S53-8. doi: 10.1097/00126334-200309011-00008.'}, {'pmid': '15247339', 'type': 'BACKGROUND', 'citation': 'Jourdain G, Ngo-Giang-Huong N, Le Coeur S, Bowonwatanuwong C, Kantipong P, Leechanachai P, Ariyadej S, Leenasirimakul P, Hammer S, Lallemant M; Perinatal HIV Prevention Trial Group. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N Engl J Med. 2004 Jul 15;351(3):229-40. doi: 10.1056/NEJMoa041305. Epub 2004 Jul 9.'}, {'pmid': '16877674', 'type': 'BACKGROUND', 'citation': 'Nightingale S, Dabis F. Evidence behind the WHO guidelines: hospital care for children: what antiretroviral agents and regimens are effective in the prevention of mother-to-child transmission of HIV? J Trop Pediatr. 2006 Aug;52(4):235-8. doi: 10.1093/tropej/fml033. No abstract available.'}, {'pmid': '16736948', 'type': 'BACKGROUND', 'citation': 'Turner D, Wainberg MA. HIV transmission and primary drug resistance. AIDS Rev. 2006 Jan-Mar;8(1):17-23.'}, {'pmid': '31487271', 'type': 'DERIVED', 'citation': 'Boltz VF, Shao W, Bale MJ, Halvas EK, Luke B, McIntyre JA, Schooley RT, Lockman S, Currier JS, Sawe F, Hogg E, Hughes MD, Kearney MF, Coffin JM, Mellors JW. Linked dual-class HIV resistance mutations are associated with treatment failure. JCI Insight. 2019 Oct 3;4(19):e130118. doi: 10.1172/jci.insight.130118.'}, {'pmid': '24938526', 'type': 'DERIVED', 'citation': 'Asmelash A, Zheng Y, Kaloustian KW, Shaffer D, Sawe F, Ogwu A, Salata R, Currier J, Hughes MD, Lockman S. Predictors of suboptimal CD4 response among women achieving virologic suppression in a randomized antiretroviral treatment trial, Africa. BMC Infect Dis. 2014 Jun 17;14:331. doi: 10.1186/1471-2334-14-331.'}, {'pmid': '24443547', 'type': 'DERIVED', 'citation': 'Boltz VF, Bao Y, Lockman S, Halvas EK, Kearney MF, McIntyre JA, Schooley RT, Hughes MD, Coffin JM, Mellors JW; OCTANE/A5208 Team. Low-frequency nevirapine (NVP)-resistant HIV-1 variants are not associated with failure of antiretroviral therapy in women without prior exposure to single-dose NVP. J Infect Dis. 2014 Mar 1;209(5):703-10. doi: 10.1093/infdis/jit635. Epub 2014 Jan 16.'}, {'pmid': '22719231', 'type': 'DERIVED', 'citation': 'Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, Chipato T, Asmelash A, Rassool M, Kimaiyo S, Shaffer D, Hosseinipour M, Mohapi L, Ssali F, Chibowa M, Amod F, Halvas E, Hogg E, Alston-Smith B, Smith L, Schooley R, Mellors J, Currier J; OCTANE (Optimal Combination Therapy After Nevirapine Exposure) ACTG A5208/OCTANE Study Team. Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLoS Med. 2012;9(6):e1001236. doi: 10.1371/journal.pmed.1001236. Epub 2012 Jun 12.'}, {'pmid': '22509297', 'type': 'DERIVED', 'citation': "Skinner-Adams TS, Butterworth AS, Porter KA, D'Amico R, Sawe F, Shaffer D, Siika A, Hosseinipour MC, Stringer E, Currier JS, Chipato T, Salata R, Lockman S, Eron JJ, Meshnick SR, McCarthy JS. The frequency of malaria is similar among women receiving either lopinavir/ritonavir or nevirapine-based antiretroviral treatment. PLoS One. 2012;7(4):e34399. doi: 10.1371/journal.pone.0034399. Epub 2012 Apr 3."}, {'pmid': '22301417', 'type': 'DERIVED', 'citation': 'Dong BJ, Zheng Y, Hughes MD, Frymoyer A, Verotta D, Lizak P, Sawe F, Currier JS, Lockman S, Aweeka FT; AIDS Clinical Trials Group Study 5208 Team. Nevirapine pharmacokinetics and risk of rash and hepatitis among HIV-infected sub-Saharan African women. AIDS. 2012 Apr 24;26(7):833-41. doi: 10.1097/QAD.0b013e328351a521.'}, {'pmid': '22123685', 'type': 'DERIVED', 'citation': "Porter KA, Cole SR, Eron JJ Jr, Zheng Y, Hughes MD, Lockman S, Poole C, Skinner-Adams TS, Hosseinipour M, Shaffer D, D'Amico R, Sawe FK, Siika A, Stringer E, Currier JS, Chipato T, Salata R, McCarthy JS, Meshnick SR. HIV-1 protease inhibitors and clinical malaria: a secondary analysis of the AIDS Clinical Trials Group A5208 study. Antimicrob Agents Chemother. 2012 Feb;56(2):995-1000. doi: 10.1128/AAC.05322-11. Epub 2011 Nov 28."}, {'pmid': '20942666', 'type': 'DERIVED', 'citation': 'Lockman S, Hughes MD, McIntyre J, Zheng Y, Chipato T, Conradie F, Sawe F, Asmelash A, Hosseinipour MC, Mohapi L, Stringer E, Mngqibisa R, Siika A, Atwine D, Hakim J, Shaffer D, Kanyama C, Wools-Kaloustian K, Salata RA, Hogg E, Alston-Smith B, Walawander A, Purcelle-Smith E, Eshleman S, Rooney J, Rahim S, Mellors JW, Schooley RT, Currier JS; OCTANE A5208 Study Team. Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1499-509. doi: 10.1056/NEJMoa0906626.'}]}, 'descriptionModule': {'briefSummary': 'Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs, protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs. This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an NNRTI with regimens including a PI in women who have never taken NVP.', 'detailedDescription': "NVP is the NNRTI of choice to prevent MTCT of HIV, especially in resource-limited settings. However, prolonged use of NVP may result in drug resistance, decreasing the efficacy of future anti-HIV regimens containing NVP. PIs are more expensive and cause different adverse effects than NNRTIs, but PI-containing regimens may be more effective than NNRTI-containing regimens in treating HIV infected women who previously took NVP for MTCT prophylaxis. This study will compare the efficacy of NNRTI- and PI-containing anti-HIV regimens in women who have previously taken NVP for MTCT of HIV and in women who have never taken NVP.\n\nThe study will last a minimum of 48 weeks. Participants will be grouped by previous NVP exposure: participants who have previously taken NVP as MTCT prophylaxis (Trial 1 participants), and participants who have never taken NVP (Trial 2 participants). Participants in each trial will be randomly assigned to one of two arms, NVP-containing arm(NVP/NVP for trial 1 participants and NoNVP/NVP for trial 2 participants) or PI-containing arm(NVP/LPV\\_r for Trial 1 participants and NoNVP/LPV\\_r for Trial 2 participants). At the start of the study, Arm NVP/NVP and NoNVP/NVP participants will receive emtricitabine (FTC) daily, tenofovir disoproxil fumarate (TDF) daily, and NVP daily for the first 14 days and then twice daily. Arm NVP/LPV\\_r and NoNVP/LPV\\_r participants will receive both FTC and TDF daily and lopinavir/ritonavir (LPV/RTV) twice daily. FTC and TDF may be replaced in either arm with the combination drug FTC/TDF.\n\nIf participants experience virologic failure, toxicity, or otherwise cannot tolerate their regimens, they will switch to a different regimen. Arm NVP/NVP and NoNVP/NVP participants will switch to a regimen of two or more nucleoside reverse transcriptase inhibitors (NRTIs) and LPV/RTV; Arm NVP/LPV\\_r and NoNVP/LPV\\_r participants will switch to a regimen of two or more NRTIs and NVP. Study visits will occur at entry and at Weeks 2, 4, 8, 12, 16, 24, and then every 12 weeks thereafter. Visits will consist of a physical exam, medication assessment, and blood collection. Participants will be asked to complete adherence questionnaires at Weeks 4, 12, 24, and every 24 weeks thereafter, and quality of life questionnaires at Weeks 24 and ever 24 weeks thereafter. Study drugs will be provided for all participants through 48 weeks after the final participant is randomized.\n\nAs per an amendment (dated April 13, 2009), participants will be asked to take part in an extension of this study. Enrollment in the extension is completely voluntary. The purpose of the extension is to monitor, in greater extent, the participants' health as they transition from study treatment to local, clinical care. During the study extension participants will not receive any medications through the study; it is expected that participants will receive their treatments through a local clinic.\n\nParticipants enrolling in the extension will enter the extension at the same time as their last visit in the current study. For the extension, participants will be asked to come back to the clinic two times for study visits: at 12 and 72 weeks after entry into the extension. Because there will be a long time between these study visits, participants will also be contacted by phone (or through some other means) close to 48 weeks after entry into the extension.\n\nAt each of these visits, participants will be asked about their health and medications, including current anti-HIV drugs. Participants will also be asked about any HIV care received outside of the study. As part of this study, investigators may need to review participants' non-study medical records and speak with their non-study care providers, to find out more about their HIV care and medical problems, and also to check results of lab tests.\n\nDuring the study extension period, participants will have blood drawn and also be tested for pregnancy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for All Participants:\n\n* HIV infected\n* CD4 count less than 200 cells/mm\\^3 within 90 days prior to study entry\n* Plasma HIV-1 RNA using standard Roche Amplicor HIV-1 Monitor Assay within 45 days prior to study entry\n* the following laboratory values obtained within 45 days prior to study entry: absolute neutrophil count\\>=750/mm\\^3;Hemoglobin\\>=7.0g/dL;platelet count\\>=50000/mm\\^3;aspartate aminotransferase (AST),Alanine aminotransferase (ALT), and alkaline phosphatase \\<=2.5 x ULN; total bilirubin \\<=2.5 x ULN\n* Normal renal function within 45 days prior to study entry\n* Willing to use acceptable forms of contraception\n* Karnofsky performance score \\>=70 on at least one occasion within 45 days prior to study entry\n* Parent or guardian willing to provide informed consent, if applicable\n* Planning to remain in the same geographical area of residence and are willing to attend study visits as required\n\nInclusion Criteria for Trial 1 Participants:\n\n* Previously received NVP for prevention of MTCT of HIV\n* Has documentation of all prior doses of NVP used for prevention of MTCT of HIV\n* Last dose of NVP for prevention of MTCT of HIV taken at least 6 months prior to study entry\n\nExclusion Criteria for All Participants:\n\n* Previously received any antiretrovirals, excluding NVP for MTCT prophylaxis for Trial 1 participants. Participants who have received up to 10 weeks of zidovudine alone and completed this course at least 6 months prior to study entry are not excluded.\n* Use of systemic cancer chemotherapy, systemic investigational agents, immunomodulators, or rifampin within 30 days of study entry\n* Pregnant or breastfeeding\n* Known allergy or sensitivity to study drugs or their formulations\n* Any condition, including drug or alcohol abuse, that, in the opinion of the investigator, may interfere with adherence to study regimens\n* Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.\n* Tuberculosis (TB) treatment within 30 days prior to study entry\n* Use of any prohibited medications within 30 days prior to study entry\n* Involuntary incarceration in a correctional facility, prison, or jail for legal reasons or in a medical facility for treatment of either a psychiatric or physical illness'}, 'identificationModule': {'nctId': 'NCT00089505', 'acronym': 'OCTANE', 'briefTitle': 'NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'Optimal Combination Therapy After Nevirapine Exposure', 'orgStudyIdInfo': {'id': 'ACTG A5208'}, 'secondaryIdInfos': [{'id': '1U01AI068636', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI068636', 'type': 'NIH'}, {'id': 'OCTANE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NVP/NVP', 'description': 'For participants who had SD NVP exposure prior to study entry. FTC, TDF, and NVP daily the first 14 days, then twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV twice daily plus two more NRTIs.', 'interventionNames': ['Drug: Emtricitabine', 'Drug: Emtricitabine/Tenofovir disoproxil fumarate', 'Drug: Nevirapine', 'Drug: Tenofovir disoproxil fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'NVP/LPV_r', 'description': 'For participants who had SD NVP exposure prior to study entry. FTC and TDF daily and LPV/RTV twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily for 14 days before taking it twice daily. plus 2 more NRTIs.', 'interventionNames': ['Drug: Emtricitabine', 'Drug: Emtricitabine/Tenofovir disoproxil fumarate', 'Drug: Lopinavir/Ritonavir', 'Drug: Tenofovir disoproxil fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'NoNVP/NVP', 'description': 'For participants who did NOT have SD NVP exposure prior to study entry.FTC, TDF, and NVP daily the first 14 days, then twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV twice daily plus two more NRTIs.', 'interventionNames': ['Drug: Emtricitabine', 'Drug: Emtricitabine/Tenofovir disoproxil fumarate', 'Drug: Nevirapine', 'Drug: Tenofovir disoproxil fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'NoNVP/LPV_r', 'description': 'For participants who did NOT have SD NVP exposure prior to study entry. FTC and TDF daily and LPV/RTV twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily for 14 days before taking it twice daily. plus 2 more NRTIs.', 'interventionNames': ['Drug: Emtricitabine', 'Drug: Emtricitabine/Tenofovir disoproxil fumarate', 'Drug: Lopinavir/Ritonavir', 'Drug: Tenofovir disoproxil fumarate']}], 'interventions': [{'name': 'Emtricitabine', 'type': 'DRUG', 'otherNames': ['FTC'], 'description': '200 mg taken orally', 'armGroupLabels': ['NVP/LPV_r', 'NVP/NVP', 'NoNVP/LPV_r', 'NoNVP/NVP']}, {'name': 'Emtricitabine/Tenofovir disoproxil fumarate', 'type': 'DRUG', 'otherNames': ['FTC/TDF'], 'description': '200/300 mg taken orally', 'armGroupLabels': ['NVP/LPV_r', 'NVP/NVP', 'NoNVP/LPV_r', 'NoNVP/NVP']}, {'name': 'Lopinavir/Ritonavir', 'type': 'DRUG', 'otherNames': ['LPV/RTV'], 'description': '400/100 mg taken orally', 'armGroupLabels': ['NVP/LPV_r', 'NoNVP/LPV_r']}, {'name': 'Nevirapine', 'type': 'DRUG', 'otherNames': ['NVP'], 'description': '200 mg taken orally', 'armGroupLabels': ['NVP/NVP', 'NoNVP/NVP']}, {'name': 'Tenofovir disoproxil fumarate', 'type': 'DRUG', 'otherNames': ['TDF'], 'description': '300 mg taken orally', 'armGroupLabels': ['NVP/LPV_r', 'NVP/NVP', 'NoNVP/LPV_r', 'NoNVP/NVP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bontleng', 'state': 'Gaborone', 'country': 'Botswana', 'facility': 'The Gaborone BHP Study Clinic'}, {'city': 'Bontleng Gaborone', 'country': 'Botswana', 'facility': 'Molepolole BHP Study Clinic, Scottish Livingstone Hospital'}, {'zip': '30100', 'city': 'Eldoret', 'country': 'Kenya', 'facility': 'Moi University International Clnical Trials Unit', 'geoPoint': {'lat': 0.52036, 'lon': 35.26993}}, {'city': 'Kericho', 'country': 'Kenya', 'facility': 'KMRI / Walter Reed Project Clinical Research Center', 'geoPoint': {'lat': -0.36774, 'lon': 35.28314}}, {'zip': '(265) 175-5056', 'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'University of North Carolina Project (UNC Project)', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'zip': '4013', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'University of KwaZulu Natal', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Hospital, Johannesburg', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'University of Witwatersrand', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Joint Clinical Research Centre (JCRC)', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Centre for Infectious Disease Research in Zambia (CIDRZ)', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'city': 'Avondale', 'state': 'Harare', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe', 'geoPoint': {'lat': -17.79611, 'lon': 31.03472}}], 'overallOfficials': [{'name': 'Shahin Lockman, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': "Brigham and Women's Hospital and Infectious Diseases Division, Department of Immunology and Infectious Diseases, Harvard School of Public Health"}, {'name': 'Frederick Sawe, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Walter Reed Project/WRAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}