Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT00099359
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2004-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D019829', 'term': 'Nevirapine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'D019888', 'term': 'Nelfinavir'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'margaretcamarca@westat.com', 'phone': '301-517-4128', 'title': 'Margaret Camarca, Project Director', 'organization': 'Westat'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'through 6 months', 'description': 'AE data collected from study entry to off study period', 'eventGroups': [{'id': 'EG000', 'title': 'ARM A (ZDV Alone)', 'description': 'ZDV, given for 6 weeks:\n\n12 mg PO BID if birthweight (BW) \\> 2000 grams 8 mg PO BID if BW \\< 2000 grams', 'otherNumAtRisk': 581, 'otherNumAffected': 492, 'seriousNumAtRisk': 581, 'seriousNumAffected': 219}, {'id': 'EG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'ZDV, given for 6 weeks:\n\n12 mg PO BID if birthweight (BW) \\> 2000 grams 8 mg PO BID if BW \\< 2000 grams\n\nAND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :\n\n12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams', 'otherNumAtRisk': 580, 'otherNumAffected': 482, 'seriousNumAtRisk': 580, 'seriousNumAffected': 211}, {'id': 'EG002', 'title': 'ARM C (ZDV + 3TC/NFV)', 'description': 'ZDV, given for 6 weeks:\n\n12 mg PO BID if birthweight (BW) \\> 2000 grams 8 mg PO BID if BW \\< 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams', 'otherNumAtRisk': 574, 'otherNumAffected': 480, 'seriousNumAtRisk': 574, 'seriousNumAffected': 252}], 'otherEvents': [{'term': 'Anaemia NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 451, 'numAffected': 286}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 402, 'numAffected': 270}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 456, 'numAffected': 287}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 294, 'numAffected': 225}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 261, 'numAffected': 119}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 334, 'numAffected': 244}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 188, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 194, 'numAffected': 170}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 177, 'numAffected': 156}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 439, 'numAffected': 335}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 429, 'numAffected': 317}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 418, 'numAffected': 325}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'seriousEvents': [{'term': 'Anaemia Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 51, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 46, 'numAffected': 39}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Axillary Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Isoimmune Haemolytic Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 83, 'numAffected': 71}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Polycythaemia Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Cyanosis Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Pulmonary Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Tachycardia Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Tricuspid Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Cardiac Disorder Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Cardiac Failure Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Cardiac Septal Defect Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Choroid Plexus Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Clubfoot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Cytomegalovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Infection Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Macrocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 47, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 52, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 43, 'numAffected': 42}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Congenital Ventricular Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Foetal Alcohol Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Genitalia External Ambiguous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Meningomyelocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Patent Ductus Arteriosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Retinoblastoma Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Trisomy 21', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Urethral Valves', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Neonatal Conjunctivitis Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Acquired Pyloric Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Diarrhoea Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 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'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Face Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Urticaria Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Exposure To Communicable Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Social Problem Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Cardiac Operation Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Eye Excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Hypertension Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}, {'term': 'Vasculitis Nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 581, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 574, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Infant HIV Infection Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}, {'value': '556', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM A (ZDV - Standard of Care)', 'description': 'ZDV (standard of care), given for 6 weeks:\n\n12 mg PO BID if birthweight (BW) \\> 2000 grams 8 mg PO BID if BW \\< 2000 grams'}, {'id': 'OG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams'}, {'id': 'OG002', 'title': 'ARM C (ZDV +3TC+NFV)', 'description': 'ZDV (standard of care) plus 3TC, given for 2 weeks:\n\n6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.046', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.', 'statisticalMethod': 'multiple comparison', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Intrapartum HIV infection at 3 Months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All infants with HIV-1 test results except infants infected at birth (i.e. in utero infections) were included in these analysis.'}, {'type': 'PRIMARY', 'title': 'Participants With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}, {'value': '556', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM A (ZDV Only)', 'description': 'ZDV only'}, {'id': 'OG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'ZDV + NVP'}, {'id': 'OG002', 'title': 'ARM C (ZDV + 3TC/NFV)', 'description': 'ZDV + 3TC/NFV'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'through age 6 months.', 'description': 'Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infant HIV-1 Infection Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ZDV Only)', 'description': 'Standard of care ( Zidovudine only). 12 mg PO BID if BW\\>2000 grams ; 8 mg PO BID if BW\\</= 2000 grams'}, {'id': 'OG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'Standard of care (Zidovudine) plus Nevirapine (NVP)\n\nNVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :\n\n12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams'}, {'id': 'OG002', 'title': 'ARM C (ZDV + 3TC + NFV)', 'description': 'Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.2432', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'multiple comparison', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'birth', 'description': 'In utero HIV-1 infection rate', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}, {'value': '574', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (ZDV Only)', 'description': 'Standard of care ( Zidovudine only). 12 mg PO BID if BW\\>2000 grams ; 8 mg PO BID if BW\\</= 2000 grams'}, {'id': 'OG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'Standard of care (Zidovudine) plus Nevirapine (NVP)\n\nNVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :\n\n12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams'}, {'id': 'OG002', 'title': 'ARM C (ZDV + 3TC + NFV)', 'description': 'Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'through age 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Covariates of HIV-1 Infection', 'timeFrame': 'through age 3 months', 'description': 'Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': '3TC and NFV Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM C (ZDV + 3TC/NFV)', 'description': 'Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL.'}], 'classes': [{'title': '(NFV-AUC-12h) 4-7 day', 'categories': [{'measurements': [{'value': '20.7', 'spread': '46.57', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '183.5'}]}]}, {'title': '(NFV-AUC-12h) 10-14 day', 'categories': [{'measurements': [{'value': '25.5', 'spread': '13.10', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '41.7'}]}]}, {'title': '(3TC-AUC-12 h) 4-7 day', 'categories': [{'measurements': [{'value': '4.0', 'spread': '4.50', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '15.6'}]}]}, {'title': '(3TC-AUC-12h) 10-14 day', 'categories': [{'measurements': [{'value': '7.9', 'spread': '4.12', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'through age 14 days', 'description': 'Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.', 'unitOfMeasure': 'ug*h/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours.'}, {'type': 'SECONDARY', 'title': 'Risk Factors for Perinatal HIV-1 Transmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '1544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infected', 'description': 'Infants infected after birth'}, {'id': 'OG001', 'title': 'Uninfected', 'description': 'Infants uninfected after birth'}], 'classes': [{'title': 'Treatment Arm C (ZDV+3TC/NFV)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Arm B (ZDV+NFV)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Arm A (ZDV only)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}]}]}, {'title': 'Illegal Substance Abuse during pregnancy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group', 'testedNonInferiority': False}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.19', 'ciUpperLimit': '0.82', 'pValueComment': 'Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '1.08', 'ciUpperLimit': '5.86', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with "NO" being reference group.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.28', 'ciLowerLimit': '1.56', 'ciUpperLimit': '3.35', 'pValueComment': 'Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'through age 3 months', 'description': 'Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model.'}, {'type': 'SECONDARY', 'title': 'NVP Pharmacokinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARM B (ZDV + NVP)', 'description': 'NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose.'}], 'classes': [{'title': 'NVP conc prior to 3rd dose', 'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000', 'lowerLimit': '165', 'upperLimit': '1728'}]}]}, {'title': 'NVP peak conc (Cmax) post 3rd dose', 'categories': [{'measurements': [{'value': '2286', 'groupId': 'OG000', 'lowerLimit': '1241', 'upperLimit': '3811'}]}]}, {'title': 'NVP conc 3-5 day post 3rd dose', 'categories': [{'measurements': [{'value': '459', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '1747'}]}]}, {'title': 'NVP conc 7 day post 3rd dose', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '652'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (ZDV Only)', 'description': 'Standard of care ( Zidovudine only). 12 mg PO BID if BW\\>2000 grams ; 8 mg PO BID if BW\\</= 2000 grams'}, {'id': 'FG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'Standard of care (Zidovudine) plus Nevirapine (NVP)\n\nNVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :\n\n12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams'}, {'id': 'FG002', 'title': 'ARM C (ZDV + 3TC + NFV)', 'description': 'Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '581'}, {'groupId': 'FG001', 'numSubjects': '580'}, {'groupId': 'FG002', 'numSubjects': '574'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '515'}, {'groupId': 'FG002', 'numSubjects': '506'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'moved out of area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The first subject was enrolled on 02/27/2004 and the study ended 02/28/2011. A total of 17 sites in Brazil, South Africa, Argentina and the U.S. participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'BG000'}, {'value': '580', 'groupId': 'BG001'}, {'value': '574', 'groupId': 'BG002'}, {'value': '1735', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (ZDV Only)', 'description': 'Standard of care ( Zidovudine only). 12 mg PO BID if BW\\>2000 grams ; 8 mg PO BID if BW\\</= 2000 grams'}, {'id': 'BG001', 'title': 'ARM B (ZDV + NVP)', 'description': 'Standard of care (Zidovudine) plus Nevirapine (NVP)\n\nNVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :\n\n12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams'}, {'id': 'BG002', 'title': 'ARM C (ZDV + 3TC + NFV)', 'description': 'Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': 'Gestational Age in Weeks', 'categories': [{'measurements': [{'value': '39', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '39', 'spread': '1.5', 'groupId': 'BG001'}, {'value': '39', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '39', 'spread': '1.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}, {'value': '882', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}, {'value': '853', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '409', 'groupId': 'BG000'}, {'value': '408', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '1219', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}, {'value': '475', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1735}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2004-12-10', 'resultsFirstSubmitDate': '2012-04-25', 'studyFirstSubmitQcDate': '2004-12-10', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-26', 'studyFirstPostDateStruct': {'date': '2004-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant HIV Infection Status', 'timeFrame': '3 months', 'description': 'Intrapartum HIV infection at 3 Months'}, {'measure': 'Participants With Serious Adverse Events', 'timeFrame': 'through age 6 months.', 'description': 'Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders'}], 'secondaryOutcomes': [{'measure': 'Infant HIV-1 Infection Status', 'timeFrame': 'birth', 'description': 'In utero HIV-1 infection rate'}, {'measure': 'Participant Deaths', 'timeFrame': 'through age 6 months'}, {'measure': 'Clinical Covariates of HIV-1 Infection', 'timeFrame': 'through age 3 months', 'description': 'Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.'}, {'measure': '3TC and NFV Pharmacokinetics', 'timeFrame': 'through age 14 days', 'description': 'Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.'}, {'measure': 'Risk Factors for Perinatal HIV-1 Transmission', 'timeFrame': 'through age 3 months', 'description': 'Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.'}, {'measure': 'NVP Pharmacokinetics', 'timeFrame': '14 days', 'description': 'Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'Perinatal', 'Prevention', 'Transmission', 'Nevirapine', 'Epivir', 'Zidovudine', 'Nelfinavir', 'ZDV', 'NVP', '3TC', 'NFV', 'Viracept', 'Viramune', 'HIV Seronegativity', 'Treatment Naive'], 'conditions': ['Disease Transmission, Vertical', 'Vertical Human Immunodeficiency Virus Transmission', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21666540', 'type': 'RESULT', 'citation': 'Mirochnick M, Nielsen-Saines K, Pilotto JH, Pinto J, Veloso VG, Rossi S, Moye J, Bryson Y, Mofenson L, Camarca M, Watts DH; NICHD HPTN 040/PACTG 1043 PROTOCOL Team. Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life. Pediatr Infect Dis J. 2011 Sep;30(9):769-72. doi: 10.1097/INF.0b013e3182242950.'}, {'pmid': '18398973', 'type': 'RESULT', 'citation': 'Mirochnick M, Nielsen-Saines K, Pilotto JH, Pinto J, Jimenez E, Veloso VG, Parsons T, Watts DH, Moye J, Mofenson LM, Camarca M, Bryson Y; NICHD/HPTN 040/PACTG 1043 Protocol Team. Nevirapine concentrations in newborns receiving an extended prophylactic regimen. J Acquir Immune Defic Syndr. 2008 Mar 1;47(3):334-7.'}, {'pmid': '22716975', 'type': 'RESULT', 'citation': 'Nielsen-Saines K, Watts DH, Veloso VG, Bryson YJ, Joao EC, Pilotto JH, Gray G, Theron G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Ceriotto M, Machado D, Bethel J, Morgado MG, Dickover R, Camarca M, Mirochnick M, Siberry G, Grinsztejn B, Moreira RI, Bastos FI, Xu J, Moye J, Mofenson LM; NICHD HPTN 040/PACTG 1043 Protocol Team. Three postpartum antiretroviral regimens to prevent intrapartum HIV infection. N Engl J Med. 2012 Jun 21;366(25):2368-79. doi: 10.1056/NEJMoa1108275.'}, {'pmid': '30216294', 'type': 'DERIVED', 'citation': 'Adachi K, Xu J, Ank B, Watts DH, Camarca M, Mofenson LM, Pilotto JH, Joao E, Gray G, Theron G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Machado DM, Ceriotto M, Morgado MG, Bryson YJ, Veloso VG, Grinsztejn B, Mirochnick M, Moye J, Nielsen-Saines K; MPH for the NICHD HPTN 040 Study Team. Congenital Cytomegalovirus and HIV Perinatal Transmission. Pediatr Infect Dis J. 2018 Oct;37(10):1016-1021. doi: 10.1097/INF.0000000000001975.'}, {'pmid': '29750766', 'type': 'DERIVED', 'citation': 'Yeganeh N, Watts DH, Xu J, Kerin T, Joao EC, Pilotto JH, Theron G, Gray G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Veloso V, Camarca M, Mofenson L, Moye J, Nielsen-Saines K. Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results From the HPTN 040/PACTG 1043 Trial. Pediatr Infect Dis J. 2018 Dec;37(12):1271-1278. doi: 10.1097/INF.0000000000002082.'}, {'pmid': '29304083', 'type': 'DERIVED', 'citation': 'Adachi K, Xu J, Yeganeh N, Camarca M, Morgado MG, Watts DH, Mofenson LM, Veloso VG, Pilotto JH, Joao E, Gray G, Theron G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Ceriotto M, Machado DM, Bryson YJ, Grinsztejn B, Moye J, Klausner JD, Bristow CC, Dickover R, Mirochnick M, Nielsen-Saines K; NICHD HPTN 040 Study Team. Combined evaluation of sexually transmitted infections in HIV-infected pregnant women and infant HIV transmission. PLoS One. 2018 Jan 5;13(1):e0189851. doi: 10.1371/journal.pone.0189851. eCollection 2018.'}, {'pmid': '28369278', 'type': 'DERIVED', 'citation': 'Adachi K, Xu J, Ank B, Watts DH, Mofenson LM, Pilotto JH, Joao E, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata MM, Gray G, Theron G, Morgado MG, Bryson YJ, Veloso VG, Klausner JD, Moye J, Nielsen-Saines K; NICHD HPTN 040 Study Team. Cytomegalovirus Urinary Shedding in HIV-infected Pregnant Women and Congenital Cytomegalovirus Infection. Clin Infect Dis. 2017 Aug 1;65(3):405-413. doi: 10.1093/cid/cix222.'}, {'pmid': '26372927', 'type': 'DERIVED', 'citation': 'Adachi K, Klausner JD, Bristow CC, Xu J, Ank B, Morgado MG, Watts DH, Weir F, Persing D, Mofenson LM, Veloso VG, Pilotto JH, Joao E, Nielsen-Saines K; NICHD HPTN 040 Study Team. Chlamydia and Gonorrhea in HIV-Infected Pregnant Women and Infant HIV Transmission. Sex Transm Dis. 2015 Oct;42(10):554-65. doi: 10.1097/OLQ.0000000000000340.'}, {'pmid': '25742089', 'type': 'DERIVED', 'citation': 'Yeganeh N, Watts HD, Camarca M, Soares G, Joao E, Pilotto JH, Gray G, Theron G, Santos B, Fonseca R, Kreitchmann R, Pinto J, Mussi-Pinhata M, Ceriotto M, Machado DM, Grinzstejn B, Veloso VG, Morgado MG, Bryson Y, Mofenson LM, Nielsen-Saines K; NICHD HPTN 040P1043 Study Team. Syphilis in HIV-infected mothers and infants: results from the NICHD/HPTN 040 study. Pediatr Infect Dis J. 2015 Mar;34(3):e52-7. doi: 10.1097/INF.0000000000000578.'}], 'seeAlsoLinks': [{'url': 'http://www.nichd.nih.gov/', 'label': 'home page of the National Institute of Child Health and Human Development'}]}, 'descriptionModule': {'briefSummary': "Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The one drug standard treatment and two combinations to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3) zidovudine/lamivudine/nelfinavir.", 'detailedDescription': "Despite the notable reductions in perinatal transmission of HIV-1 with antiretroviral therapy and other interventions, perinatal transmission continues to occur at rates of 20-30% among pregnant women who are not identified as HIV-1-infected and/or are not provided with antiretroviral therapy. The optimum treatment strategy for prevention of transmission of HIV-1 to infants born to these women is unknown. No trials have evaluated the efficacy of neonatal antiretroviral therapy alone but observational data suggest benefit from zidovudine (ZDV) therapy given to the infant beginning within 48 hours of birth and continued for six weeks. This protocol will compare the safety and efficacy of three antiretroviral regimens administered in the neonatal period: Arm A- ZDV, Arm B- ZDV plus nevirapine (NVP), and Arm C- ZDV plus nelfinavir (NFV) and lamivudine (3TC). Two regimens were selected based on expected antiretroviral activity, pharmacokinetic data, and toxicity profiles. Standard of care (6 weeks of ZDV) alone will be compared to the 6 weeks of ZDV plus either 3 doses of NVP or 2 weeks of 3TC and NFV. Arm B (ZDV + NVP) is the regimen expected to provide the best profile when factors of efficacy, safety, cost, acceptability and convenience are considered. The comparison of Arms B and C is also of considerable interest since the 2-drug Arm B is easier to implement and less expensive than the triple drug Arm C. Although triple drug therapies have been recommended for post-exposure prophylaxis for needle-stick injuries in high-risk circumstances, it is unknown whether the triple drug arm will provide better efficacy than the 2-drug arm for post-exposure prophylaxis of the infant.\n\nThis open-label study is expected to accrue 1731 infants of women identified in labor as being HIV positive or who are HIV positive but have not received antiretroviral medication during the pregnancy. If eligible the infant will be randomized at birth to one of three aforementioned treatment arms. Medical history, social, demographic, physical exam, RNA and T- lymphocyte data are collected on the mother during the delivery visit. The infant will have a birth visit and then return for 1-week, 2-week, 4-week, 3-month and a final 6-month visit. Infant evaluations will include: a medical history and physical exam, DNA testing, CBC and liver function tests, cells for long-term storage and RNA/CD4/CD8 testing if HIV positive. The initial study drug doses will be given to the infant while in the hospital. Mothers will administer the infants' remaining treatment doses at home depending on ability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInfants who meet all of the following criteria are eligible for the study:\n\n* Mother known to be HIV-1-infected prior to labor or identified at the time of labor or \\<48 hours postpartum. HIV-1 infection for the purposes of enrollment into this study is defined as: (a) Single positive HIV-1 rapid test in mother or her infant; or (b) Historical documentation of a positive HIV-1 diagnostic test confirmed by repeat diagnostic testing for HIV-1 according to country guidelines in mother (written documentation of test results must be present in the medical record).\n* Maternal written informed consent for study participation.\n* Mother has not received any antiretroviral therapy during the current pregnancy prior to the onset of labor and delivery; women may have received intravenous or oral ZDV during labor. Women may have received any antiretroviral therapy in previous pregnancies for prevention of vertical HIV-1 transmission.\n* Infant is \\<48 hours old. Infant may have received up to 48 hours of ZDV as standard care before study enrollment.\n\nExclusion Criteria:\n\nInfants who meet any of the following criteria will be excluded from the study:\n\n* Extreme prematurity (\\< 32 weeks of gestation).\n* Birth weight \\<1500 grams.\n* Presence of life-threatening conditions.\n* Inability to take oral medication throughout the first 48 hours of life (must be able to receive oral medication by age 48 hours).\n* Maternal inability to provide informed consent because of a lack of a conscious state, psychiatric conditions, or language barriers.\n* Mother received any antiretroviral therapy during labor and delivery other than intravenous or oral ZDV.'}, 'identificationModule': {'nctId': 'NCT00099359', 'briefTitle': 'Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission', 'orgStudyIdInfo': {'id': 'NICHD/HPTN 040 (P1043)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Standard of care ( Zidovudine only)', 'interventionNames': ['Drug: Zidovudine']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Standard of care (Zidovudine) plus Nevirapine', 'interventionNames': ['Drug: Nevirapine (NVP)']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Standard of Care (Zidovudine) plus 2 weeks of Epivir and Nelfinavir', 'interventionNames': ['Drug: Epivir (3TC)', 'Drug: Nelfinavir (NFV)']}], 'interventions': [{'name': 'Zidovudine', 'type': 'DRUG', 'otherNames': ['Retrovir'], 'description': 'Given for 6 weeks. 12mg PO BID if birthweight (BW) \\> 2000 grams 8 mg PO BID if BW \\< 2000 grams', 'armGroupLabels': ['A']}, {'name': 'Nevirapine (NVP)', 'type': 'DRUG', 'otherNames': ['Viramune'], 'description': 'Standard of Care (Zidovudine) plus\n\nNVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :\n\n12 mg PO per dose if BW \\> 2000 grams, 8 mg PO per dose if BW \\< 2000 grams', 'armGroupLabels': ['B']}, {'name': 'Epivir (3TC)', 'type': 'DRUG', 'otherNames': ['Lamivudine'], 'description': 'Stand of care (Zidovudine) plus\n\n3TC, given for 2 weeks: 6 mg po bid if BW \\> 2000 grams 4 mg po bid if BW \\< 2000 grams AND\n\nNFV, given for 2 weeks:\n\n200 mg po bid if BW \\> 3000 grams 150 mg po bid if BW \\> 2,000 - 3000 grams 100 mg PO BID if BW \\< 2000 grams', 'armGroupLabels': ['C']}, {'name': 'Nelfinavir (NFV)', 'type': 'DRUG', 'otherNames': ['Viracept'], 'description': '200 mg BID if birth weight (BW) \\> 3000 grams for 2 weeks;150 mg BID if BW \\> 2000-3000 grams for 2 weeks; 100 mg BID BW \\</= 2000 grams for 2 weeks', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '32610-0296', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of FL', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of FL-HSC', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Medical and Dental School of NJ-Newark Campus', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital I. G. A. Dr. Diego Paroissien', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Minas Gerais (UFMG)', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '14024-250', 'city': 'São Paulo', 'state': 'Ribeirão Preto', 'country': 'Brazil', 'facility': 'Universidade de Sao Paulo (USP) , MD', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '90430001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Fêmina S.A. Unidade Perinatal de Transmissão Vertical', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90850 530', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Santa Casa (HSC)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '91350-200', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Nossa Senhora da Conceicao (GHC)', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '20221-903', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital dos Servidores do Estado (HSE)', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '26030-380', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Geral de Novo Iguacu', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '04939-002', 'city': 'São Paulo', 'country': 'Brazil', 'facility': '5088 - Universidade Federal de Sao Paulo (UFSP)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '00936-8344', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'San Juan Hospital', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Tygerberg Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Chris Hani Baragwanath Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Karin Nielsen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}