Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-27 @ 5:34 AM
Study NCT ID:
NCT00955968
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2009-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
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': 'D023241', 'term': 'Antiretroviral Therapy, Highly Active'}], 'ancestors': [{'id': 'D004359', 'term': 'Drug Therapy, Combination'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mallen@fhi360.org', 'phone': '(919) 405-1429', 'title': 'Melissa Allen, Director, IMPAACT Operations Center', 'organization': 'Family Health International (FHI 360)'}, 'certainAgreement': {'otherDetails': 'In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From study entry to off study date (an average of 125 weeks of follow-up).', 'description': 'The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of \\>=Grade 3 (with exceptions to all grades of creatinine and all grade \\>=2 renal, hematologic, and hepatic abnormalities), and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used.', 'eventGroups': [{'id': 'EG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes', 'otherNumAtRisk': 827, 'deathsNumAtRisk': 827, 'otherNumAffected': 778, 'seriousNumAtRisk': 827, 'deathsNumAffected': 2, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes', 'otherNumAtRisk': 825, 'deathsNumAtRisk': 825, 'otherNumAffected': 765, 'seriousNumAtRisk': 825, 'deathsNumAffected': 4, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 67}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cervicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 71}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 97}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 71}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 61}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 57}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 527}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 500}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 51}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 91}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 123}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 76}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 100}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 459}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 427}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 88}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 176}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 118}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ergot poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abortion incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Foetal death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 827, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 825, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.27'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.25', 'upperLimit': '0.38'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.19', 'ciUpperLimit': '2.40', 'pValueComment': '5% alpha level and 2-sided test', 'estimateComment': 'HR reflects Continue HAART : Stop HAART', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of AIDS - Defining Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.14'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.19'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.11', 'ciUpperLimit': '4.01', 'pValueComment': '5% alpha level and 2-sided test', 'estimateComment': 'HR reflects Continue HAART : Stop HAART', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.14'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.25'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '0.09', 'ciUpperLimit': '2.81', 'pValueComment': '5% alpha level and 2-sided test', 'estimateComment': 'HR reflects Continue HAART : Stop HAART', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of HIV/AIDS Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'groupId': 'OG000', 'lowerLimit': '1.07', 'upperLimit': '1.62'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '1.16', 'upperLimit': '1.73'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.60', 'pValueComment': '5% alpha level and 2-sided test', 'estimateComment': 'HR reflects Continue HAART : Stop HAART', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of HIV/AIDS Related Events or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.75'}, {'value': '1.57', 'groupId': 'OG001', 'lowerLimit': '1.30', 'upperLimit': '1.91'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.52', 'pValueComment': '5% alpha level and 2-sided test', 'estimateComment': 'HR reflects Continue HAART : Stop HAART', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.09', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '3.79'}, {'value': '5.37', 'groupId': 'OG001', 'lowerLimit': '4.60', 'upperLimit': '6.28'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.80', 'pValueComment': '5% alpha level and 2-sided test', 'estimateComment': 'HR reflects Continue HAART : Stop HAART', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Grade 2 and Above Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '21.4'}, {'value': '15.6', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '18.4'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.03', 'pValueComment': '5% alpha level and 2-sided test', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)', 'description': 'The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method.', 'unitOfMeasure': 'New cases per 100 person - years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Cardiovascular or Other Metabolic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Other Targeted Medical Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}, {'type': 'SECONDARY', 'title': 'Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.', 'description': 'VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '156 women who were VFs had antiretroviral drug resistance testing performed.'}, {'type': 'SECONDARY', 'title': 'Medication Adherence - Last Time Missed Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '672', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '672', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never skipped medications', 'measurements': [{'value': '489', 'groupId': 'OG000'}]}, {'title': 'More than 1 month ago', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': 'Within the past 4 weeks', 'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '652', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never skipped medications', 'measurements': [{'value': '411', 'groupId': 'OG000'}]}, {'title': 'More than 1 month ago', 'measurements': [{'value': '97', 'groupId': 'OG000'}]}, {'title': 'Within the past 4 weeks', 'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never skipped medications', 'measurements': [{'value': '399', 'groupId': 'OG000'}]}, {'title': 'More than 1 month ago', 'measurements': [{'value': '92', 'groupId': 'OG000'}]}, {'title': 'Within the past 4 weeks', 'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Continue HAART arm who had evaluations done at the respective weeks'}, {'type': 'SECONDARY', 'title': 'Medication Adherence - How Closely Followed Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '673', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Some of the time', 'measurements': [{'value': '130', 'groupId': 'OG000'}]}, {'title': 'All of the time', 'measurements': [{'value': '520', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Some of the time', 'measurements': [{'value': '173', 'groupId': 'OG000'}]}, {'title': 'All of the time', 'measurements': [{'value': '461', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '637', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Some of the time', 'measurements': [{'value': '153', 'groupId': 'OG000'}]}, {'title': 'All of the time', 'measurements': [{'value': '459', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Continue HAART arm who had evaluations done at the respective weeks'}, {'type': 'SECONDARY', 'title': 'Medication Adherence - How Often Follow Instructions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '667', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '667', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Some of the time', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}, {'title': 'All of the time', 'measurements': [{'value': '166', 'groupId': 'OG000'}]}, {'title': 'No special instructions', 'measurements': [{'value': '439', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '650', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Some of the time', 'measurements': [{'value': '61', 'groupId': 'OG000'}]}, {'title': 'All of the time', 'measurements': [{'value': '194', 'groupId': 'OG000'}]}, {'title': 'No special instructions', 'measurements': [{'value': '389', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '637', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Some of the time', 'measurements': [{'value': '74', 'groupId': 'OG000'}]}, {'title': 'All of the time', 'measurements': [{'value': '190', 'groupId': 'OG000'}]}, {'title': 'No special instructions', 'measurements': [{'value': '365', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Continue HAART arm who had evaluations done at the respective weeks'}, {'type': 'SECONDARY', 'title': 'Medication Adherence - Missed Dose Within Past 4 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '592', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '635', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '564', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '544', 'groupId': 'OG000'}]}, {'title': 'Yes', 'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Continue HAART arm who had evaluations done at the respective weeks'}, {'type': 'SECONDARY', 'title': 'Quality of Life - General Health Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'classes': [{'title': 'week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}, {'title': 'Very good', 'measurements': [{'value': '262', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '327', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}, {'title': 'Very good', 'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '222', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}, {'title': 'Very good', 'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}, {'title': 'Good', 'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}, {'title': 'Fair', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Poor', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0, 48 and 96', 'description': 'Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) - Health Rating Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}, {'value': '825', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'classes': [{'title': 'week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '819', 'groupId': 'OG000'}, {'value': '820', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.7', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '83.0', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}, {'value': '702', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.3', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '85.4', 'spread': '14.0', 'groupId': 'OG001'}]}]}, {'title': 'week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '86.3', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, 48 and 96', 'description': 'QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants except one who was excluded as she withdrew from study on the day she was randomized'}, {'type': 'SECONDARY', 'title': 'Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'timeFrame': 'Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.'}, {'type': 'SECONDARY', 'title': 'Cost Effectiveness and Feasibility of Treatment Models', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue HAART', 'description': 'Participants would continue receiving HAART after delivery or other pregnancy outcome.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}, {'id': 'OG001', 'title': 'Stop HAART', 'description': 'Participants would stop receiving HAART after delivery or other pregnancy outcome and resume HAART when protocol-specified criteria were met.\n\nHighly active antiretroviral therapy (HAART): A combination of three or more HIV medications belonging to two or more drug classes'}], 'timeFrame': 'Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'FG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '828'}, {'groupId': 'FG001', 'numSubjects': '825'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '691'}, {'groupId': 'FG001', 'numSubjects': '699'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '126'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '52'}]}]}], 'recruitmentDetails': 'There were 1653 participants randomized to the study with enrollments from the US, Argentina, Botswana, Brazil, China, Haiti, and Thailand. The first participant was randomized on January 2010. The last participant was randomized in November 2014.', 'preAssignmentDetails': 'There were 1917 participants screened for the study, 264 of these failed screening and were not enrolled. The most common reasons for screening failure were CD4 cell count out of range, did not return for consent, test results unavailable on protocol specified time frame, not willing to participate, and not willing to remain on antiretrovirals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.'}, {'id': 'BG001', 'title': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '809', 'groupId': 'BG000'}, {'value': '807', 'groupId': 'BG001'}, {'value': '1616', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '32'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Haiti', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}, {'title': 'Botswana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}]}, {'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '412', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': 'American Indian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black African', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}, {'title': 'Black of African origin', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Mestizo', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Mixed Black', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Mixed native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native (native Brazilian-Xavante/Kaigang/Guarani)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Subject does not know', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Race not available to clinic', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '812', 'groupId': 'BG000'}, {'value': '801', 'groupId': 'BG001'}, {'value': '1613', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'BG000', 'lowerLimit': '21.7', 'upperLimit': '28.0'}, {'value': '24.6', 'groupId': 'BG001', 'lowerLimit': '21.8', 'upperLimit': '28.3'}, {'value': '24.5', 'groupId': 'BG002', 'lowerLimit': '21.8', 'upperLimit': '28.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Baseline weight and height measure were not completed for some participants'}, {'title': 'WHO stage at entry', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '1650', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Clinical Stage I', 'measurements': [{'value': '810', 'groupId': 'BG000'}, {'value': '811', 'groupId': 'BG001'}, {'value': '1621', 'groupId': 'BG002'}]}, {'title': 'Clinical Stage II', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Clinical Stage III', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Clinical staging of HIV/AIDS by WHO definitions (WHO, 2007). Staging is based on clinical findings that guide the diagnosis, evaluation, and management of HIV/AIDS. Clinical stages are categorized as 1 through 4, progressing from primary HIV infection to advanced HIV/AIDS. These stages are defined by specific clinical conditions or symptoms as described in the reference (see the References in the Protocol Section).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline WHO staging criteria was not completed for some participants.'}, {'title': 'Duration of Antiretroviral therapy (ART) prior to study entry', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '23'}, {'value': '17', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '23'}, {'value': '17', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'ART regimen prior to entry', 'classes': [{'title': 'HAART including boosted PI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '629', 'groupId': 'BG000'}, {'value': '612', 'groupId': 'BG001'}, {'value': '1241', 'groupId': 'BG002'}]}]}, {'title': 'HAART including non-boosted PI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'HAART including NNRTI [EFV]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}, {'title': 'HAART including NNRTI [NVP]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'HAART including NNRTI [RPV]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'HAART including NNRTI and PI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Three or more NRTIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Zero NRTIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'HAART including II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'HAART including PI and II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'PI - Protease Inhibitor, NNRTI - Non Nucleoside Reverse Transcriptase Inhibitor, EFV - Efavirenz, NVP - Nevirapine, RPV - Rilpivirine, NRTI - Nucleoside Reverse Transcriptase Inhibitor, II - Integrase Inhibitor', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis B surface antigen', 'classes': [{'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1640', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1640', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '771', 'groupId': 'BG000'}, {'value': '768', 'groupId': 'BG001'}, {'value': '1539', 'groupId': 'BG002'}]}]}, {'title': 'Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1640', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not obtained, Hep B antibody +ve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '821', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1640', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline Hepatitis B surface antigen was not obtained for some participants'}, {'title': 'Hepatitis B surface antibody', 'classes': [{'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '1649', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '263', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '511', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '1649', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '424', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '849', 'groupId': 'BG002'}]}]}, {'title': 'Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '1649', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not obtained, Hep B antibody +ve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '1649', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline Hepatitis B surface antibody was not obtained for some participants'}, {'title': 'CD4+ cell count on ART', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '696', 'groupId': 'BG000', 'lowerLimit': '575', 'upperLimit': '870'}, {'value': '695', 'groupId': 'BG001', 'lowerLimit': '575', 'upperLimit': '868'}, {'value': '696', 'groupId': 'BG002', 'lowerLimit': '575', 'upperLimit': '869'}]}]}], 'paramType': 'MEDIAN', 'description': 'CD4+ cell count was evaluated at screening', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Pre-ART CD4+ cell count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'BG000'}, {'value': '825', 'groupId': 'BG001'}, {'value': '1652', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '550', 'groupId': 'BG000', 'lowerLimit': '461', 'upperLimit': '682'}, {'value': '548', 'groupId': 'BG001', 'lowerLimit': '463', 'upperLimit': '677'}, {'value': '549', 'groupId': 'BG002', 'lowerLimit': '462', 'upperLimit': '680'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Plasma HIV Viral Load', 'classes': [{'title': '< 400 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1641', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '744', 'groupId': 'BG000'}, {'value': '742', 'groupId': 'BG001'}, {'value': '1486', 'groupId': 'BG002'}]}]}, {'title': '400 - <1000 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1641', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': '1000- <10000 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1641', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': '10000-<100000 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1641', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': '>=100000 copies/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '822', 'groupId': 'BG000'}, {'value': '819', 'groupId': 'BG001'}, {'value': '1641', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline Plasma HIV viral load was not obtained for some participants'}], 'populationDescription': 'All the participants who were randomized to the study with the exception of one participant who was excluded as she withdrew from the study on the day she was randomized'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1653}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2009-08-07', 'resultsFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2009-08-07', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-19', 'studyFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of AIDS - Defining Illness', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'Serious non - AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rate of Deaths', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rate of HIV/AIDS Related Events', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rate of HIV/AIDS Related Events or Death', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rate of Grade 2 and Above Toxicity', 'timeFrame': 'All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symptoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)', 'description': 'The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method.'}, {'measure': 'Incidence Rate of Cardiovascular or Other Metabolic Events', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}, {'measure': 'Incidence Rate of Other Targeted Medical Conditions', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}, {'measure': 'Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death', 'timeFrame': 'From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}, {'measure': 'Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm', 'timeFrame': 'At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.', 'description': 'VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2)'}, {'measure': 'Medication Adherence - Last Time Missed Medications', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.'}, {'measure': 'Medication Adherence - How Closely Followed Schedule', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.'}, {'measure': 'Medication Adherence - How Often Follow Instructions', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.'}, {'measure': 'Medication Adherence - Missed Dose Within Past 4 Days', 'timeFrame': 'week 0, 48 and 96', 'description': 'Medication adherence was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.'}, {'measure': 'Quality of Life - General Health Outcome', 'timeFrame': 'week 0, 48 and 96', 'description': 'Quality of Life was evaluated by a self reported questionnaire. The number of participants who indicated predefined choice is provided.'}, {'measure': 'Quality of Life (QoL) - Health Rating Score', 'timeFrame': 'week 0, 48 and 96', 'description': 'QoL - health rating score was evaluated by a self reported questionnaire. Health rating score of 0 was indicative of death or worst possible health and a score of 100 was being in perfect or best possible health and the mean of score is calculated. Higher scores indicate better Quality of Life (QoL). The range is 0-100 units on a scale'}, {'measure': 'Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers', 'timeFrame': 'Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.'}, {'measure': 'Cost Effectiveness and Feasibility of Treatment Models', 'timeFrame': 'Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).', 'description': 'This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated by NIH.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Infection', 'HAART', 'Maternal Health'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 with Clarification dated August 2009, which can be found on the DAIDS RSC Web site: http://rsc.tech-res.com'}, {'type': 'BACKGROUND', 'citation': 'Manual for Expedited Reporting of Adverse Events to DAIDS, Version 2.0, January 2010.'}, {'pmid': '28489856', 'type': 'DERIVED', 'citation': 'Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, Santos B, Aurpibul L, Losso M, Pierre MF, Weinberg A, Gnanashanmugam D, Chakhtoura N, Klingman K, Browning R, Coletti A, Mofenson L, Shapiro D, Pilotto J; 1077HS PROMISE Team. Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 >/= 400 cells/mm3. PLoS One. 2017 May 10;12(5):e0176009. doi: 10.1371/journal.pone.0176009. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'http://www.impaactnetwork.org/studies/1077HS.asp', 'label': 'Related Info'}, {'url': 'http://apps.who.int/iris/handle/10665/43699', 'label': 'WHO Case Definitions of HIV for Surveillance and Revised Clinical Staging and Immunological Classification of HIV-related Disease in Adults and Children (World Health Organization 2007).'}]}, 'descriptionModule': {'briefSummary': 'This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.', 'detailedDescription': 'This randomized strategy trial addressed therapeutic questions for women from regions where antepartum HAART for PMTCT (for all CD4+ cell counts) and postpartum formula feeding is standard of care, and who also had both a pre-HAART CD4+ cell count \\>400 cells/mm\\^3 and a screening (on-HAART) CD4+ cell count \\> 400 cells/mm\\^3. For these women, the objectives related to the relative efficacy and safety of continuing HAART (when it is no longer used for PMTCT) versus discontinuing HAART.\n\nPotential participants were identified/recruited and consented during pregnancy or after delivery or other pregnancy outcome. Study-specific screening was initiated in the third trimester or after pregnancy outcome. Women who were screened for the study were counseled to continue their HAART until they were randomized.\n\nRandomization would occur within 0-42 days after pregnancy outcome. Women who did not carry their pregnancy to the third trimester but otherwise meet study eligibility criteria could be enrolled.\n\nParticipants were randomized to one of the two study arms:\n\nArm A: Continuation of HAART Arm B: Discontinuation of HAART and resume HAART when protocol-specified criteria were met\n\nParticipants were to be followed until 84 weeks after the last participant was randomized.\n\nKey evaluations were conducted at Screening, Entry, post entry visits were scheduled to take place 4 weeks after entry, 12 weeks after entry, and every 12 weeks thereafter. Key evaluations included physical examinations, clinical assessments, and blood collection.\n\nOn 7 July 2015, the study sites received formal communications regarding the results of the Strategic Timing of Antiretroviral Treatment (START) study and associated changes were implemented to the 1077HS study in response to these results. All sites were instructed that all women in the 1077HS study were to be informed of the START study results and that antiretroviral therapy (ART) was recommended for all women based on the START study results.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age ≥ 18 years or who had attained the minimum age of independent consent, as defined by the local Institutional Review Board (IRB), and were willing and able to provide written informed consent Additionally, at sites with IRB approval to enroll younger participants, women age 16-17 years who were willing and able to provide written assent and whose parent or legal guardian was willing and able to provide written informed consent\n* Confirmed HIV infection, documented by positive results from two samples collected at different time points prior to study entry, using protocol-specified tests (see protocol for more details)\n* Documentation of hepatitis B surface antibody (HBsAb) status and hepatitis B surface antigen (HBsAg) status (if antibody was negative) within 12 months prior to study entry\n* Within 0-42 days after pregnancy outcome\n* Antiretroviral treatment naïve, defined as \\< 14 days of one or more antiretroviral agents, prior to therapy initiated during current pregnancy\n* Receipt of at least four weeks of HAART prior to study entry, at least two weeks of which must have been prior to pregnancy outcome (up to seven consecutive days of missed therapy is permitted)\n* CD4+ cell count ≥ 400 cells/mm\\^3 on a specimen obtained within 120 days prior to initiation of HAART for current pregnancy\n* CD4+ cell count ≥ 400 cells/mm\\^3 on a specimen obtained on HAART and within 45 days prior to study entry\n* The following laboratory values on a specimen obtained within 45 days prior to study entry:\n\n * Absolute neutrophil count ≥ 750/mm\\^3\n * Hemoglobin ≥ 7.0 g/dL\n * Platelet count ≥ 50,000/mm\\^3\n * AST (SGOT), ALT (SGPT), and alkaline phosphatase ≤ 2.5 x ULN\n* Estimated creatinine clearance of ≥ 60mL/min within 45 days prior to entry using the Cockcroft-Gault formula\n* Intent to remain in current geographical area of residence for the duration of the study\n* Willingness to attend study visits as required by the study\n\nExclusion Criteria:\n\n* Previous participation in PROMISE (P1077BF - NCT01061151)\n* Clinical indication for HAART including any World Health Organization (WHO) Clinical Stage 3 or 4 condition, prior or current tuberculosis disease (a positive (Purified protein Derivative) PPD test alone was not considered exclusionary), and/or any other clinical indication per country-specific treatment guidelines\n* Clinically significant illness or condition requiring systemic treatment and/or hospitalization within 30 days prior to study entry\n* Social or other circumstances which, in the opinion of the site investigator, would hinder long-term follow up\n* Use of any prohibited medications within 14 days prior to study entry (refer to the study MOP for a list of prohibited medications)\n* Current compulsory detention (involuntary incarceration) in a correctional facility, prison, or jail for legal reasons or compulsory detention in a medical facility for treatment of either a psychiatric or physical (e.g., infectious disease) illness\n* Currently breastfeeding or planning to breastfeed\n* Current documented conduction heart defect (specialized assessments to rule out this condition were not required; a heart murmur alone and/or type 1 second-degree atrioventricular block (also known as Mobitz I or Wenckebach) was not considered exclusionary)\n* Known evidence of HBV DNA levels \\>2000 IU/mL (approximately 10,000 copies/mL) in the presence of elevated (grade 1 and higher) ALT (HBV DNA testing was not required for study screening or enrollment but was considered to determine whether treatment for HBV was indicated)'}, 'identificationModule': {'nctId': 'NCT00955968', 'briefTitle': 'IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women', 'organization': {'class': 'NETWORK', 'fullName': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group'}, 'officialTitle': 'IMPAACT 1077HS: HAART Standard Version of the Promoting Maternal and Infant Survival Everywhere (PROMISE) Study', 'orgStudyIdInfo': {'id': 'IMPAACT 1077HS'}, 'secondaryIdInfos': [{'id': 'U01AI068632', 'link': 'https://reporter.nih.gov/quickSearch/U01AI068632', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continue HAART', 'description': 'Continue receiving HAART within 0-42 days after delivery or other pregnancy outcome.', 'interventionNames': ['Drug: Highly active antiretroviral therapy (HAART)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stop HAART', 'description': 'Stop receiving HAART within 0-42 days after delivery or other pregnancy outcome and resume HAART when protocol specified criteria were met.', 'interventionNames': ['Drug: Highly active antiretroviral therapy (HAART)']}], 'interventions': [{'name': 'Highly active antiretroviral therapy (HAART)', 'type': 'DRUG', 'description': 'A combination of three or more HIV medications belonging to two or more drug classes.\n\nThe preferred study-supplied HAART regimen was lopinavir/ritonavir (LPV/RTV) plus fixed dose combination tenofovir/emtricitabine (TDF/FTC). Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose combination tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV), didanosine (ddI), atazanavir (ATV), raltegravir (RAL), and ritonavir (RTV). While LPV/RTV plus TDF/FTC was the preferred study-supplied regimen, the study clinicians in conjunction with participants would determine the optimal drug combination for each participant.', 'armGroupLabels': ['Continue HAART', 'Stop HAART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90007', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California MCA Center (5048)', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA (5112)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Mother-Child-Adolescent HIV Program (4601)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor (UCLA) Medical Center (5045)', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado (5052)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20059', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University (5044)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University (1008)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center (5023)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': "Children's Diagnostic and Treatment Center (5055)", 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida at Jacksonville (5051)', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Pediatric/Perinatal Clinical Research Site (4201)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida at Tampa (5018)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H Lurie Children's Hospital of Chicago (4001)", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University (5095)', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine (5092)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center (5011)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Wayne State University/Children's Hospital of Michigan (5041)", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Metropolitan Hospital (5003)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook University Medical Center (5040)', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx-Lebanon Hospital Center (5114)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center (5013)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center (4701)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pitt CRS (1001)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St Jude Children's Research Hospital (6501)", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine Texas Children's Hospital (3801)", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital (5017)", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital General de Agudos (5082)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Gaborone Prevention/Treatment Clinical Research Site (12701)', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Molepolole Prevention/Treatment Clinical Research Site (12702)', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': 'School of Medicine, University of Minas Gerais - FUNDEP (5073)', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Caxias do Sul', 'country': 'Brazil', 'facility': 'University Caxias do Sul (5084)', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora da Conceicao (5117)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital Santa Casa (5098)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital dos Servidores do Estado (5072)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Geral De Nova Igaucu (5097)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Puericultura E Pediatria Martagao Geseira - FUJB (5071)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Ribeirao Preto Medical School, University of Sao Paulo (5074)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Guangxi Center for HIV/AIDS Prevention and Control (30274)', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Port-au-Prince', 'country': 'Haiti', 'facility': 'Les Centres GHESKIO (30022)', 'geoPoint': {'lat': 18.54349, 'lon': -72.33881}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'IMPACTA Barranco Clinical Research Site (11301)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'IMPACTA San Miguel Clinical Research Site (11302)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan City Hospital (5031)', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico Pediatric HIV/AIDS Research Program (6601)', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Ratchathewi,', 'country': 'Thailand', 'facility': 'Siriraj Hospital Mahidol University CRS (5115)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bhumibol Adulyadej Hospital (5124)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '22000', 'city': 'Chanthaburi', 'country': 'Thailand', 'facility': 'Prapokklao Hospital (5123)', 'geoPoint': {'lat': 12.60961, 'lon': 102.10447}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University (31784)', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Chiang Rai', 'country': 'Thailand', 'facility': 'Chiang Rai Regional Hospital (5116)', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'zip': '20000', 'city': 'Chon Buri', 'country': 'Thailand', 'facility': 'Chonburi Hospital (5125)', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}, {'zip': '56000', 'city': 'Phayao', 'country': 'Thailand', 'facility': 'Phayao Provincial Hospital (5122)', 'geoPoint': {'lat': 19.19203, 'lon': 99.87883}}], 'overallOfficials': [{'name': 'Judith S. Currier, MD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Maternal Pediatric Adolescent AIDS Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}