Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-28 @ 11:05 PM
Study NCT ID:
NCT00855335
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], '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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069454', 'term': 'Darunavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C451734', 'term': 'etravirine'}, {'id': 'D000068696', 'term': 'Rilpivirine'}, {'id': 'D000069547', 'term': 'Cobicistat'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Medical Leader, Medical Department', 'organization': 'Janssen Scientific Affairs, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Follow up phase (16 weeks after postpartum)', 'description': 'Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. The Adverse events were reported as per MedDRA Version 11.1 for darunavir and rilpivirine ; MeDRA version 16.0 for etravirine.', 'eventGroups': [{'id': 'EG000', 'title': 'Darunavir 600 mg /Ritonavir 100 mg Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.', 'otherNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.', 'otherNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.', 'otherNumAtRisk': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.', 'otherNumAtRisk': 19, 'otherNumAffected': 8, 'seriousNumAtRisk': 19, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Anaemia of Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Pitting Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Seasonal Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Fungal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Genital Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Tinea Pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Vaginal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Vaginitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Eye Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Blood Albumin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Blood Amylase 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Medical Observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Gestational Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Chorioamnionitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Intra-Uterine Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Oligohydramnios', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Premature Rupture of Membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1 and 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Predose (Trough) Plasma Concentration (C0h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG005', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG006', 'title': 'Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG007', 'title': 'Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Postpartum (6-12 W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3608', 'spread': '2812', 'groupId': 'OG000'}, {'value': '491.4', 'spread': '472.4', 'groupId': 'OG001'}, {'value': '2481', 'spread': '2183', 'groupId': 'OG002'}, {'value': '147', 'spread': '198', 'groupId': 'OG003'}, {'value': '281', 'spread': '193', 'groupId': 'OG004'}, {'value': '127', 'spread': '97.0', 'groupId': 'OG005'}, {'value': '2811', 'spread': '2296', 'groupId': 'OG006'}, {'value': '134', 'spread': '145', 'groupId': 'OG007'}]}]}, {'title': '2nd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2323', 'spread': '1140', 'groupId': 'OG000'}, {'value': '225.9', 'spread': '127.5', 'groupId': 'OG001'}, {'value': '1793', 'spread': '964', 'groupId': 'OG002'}, {'value': '94.2', 'spread': '102', 'groupId': 'OG003'}, {'value': '439', 'spread': '212', 'groupId': 'OG004'}, {'value': '75.6', 'spread': '36.2', 'groupId': 'OG005'}, {'value': '540', 'spread': '803', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Here, NA indicates that the data is not reported because the predose plasma concentrations were Below Quantification Limit (BQL) less than (\\<) 5.00 ng/mL.', 'groupId': 'OG007'}]}]}, {'title': '3rd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3280', 'spread': '1466', 'groupId': 'OG000'}, {'value': '236.0', 'spread': '108.08', 'groupId': 'OG001'}, {'value': '1528', 'spread': '1184', 'groupId': 'OG002'}, {'value': '74.6', 'spread': '90.2', 'groupId': 'OG003'}, {'value': '413', 'spread': '78.2', 'groupId': 'OG004'}, {'value': '78.0', 'spread': '39.1', 'groupId': 'OG005'}, {'value': '824', 'spread': '630', 'groupId': 'OG006'}, {'value': '30.1', 'spread': '51.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Minimum Plasma Concentration (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG005', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG006', 'title': 'Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG007', 'title': 'Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Postpartum (6-12 W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2851', 'spread': '2216', 'groupId': 'OG000'}, {'value': '264.7', 'spread': '259.8', 'groupId': 'OG001'}, {'value': '1473', 'spread': '1141', 'groupId': 'OG002'}, {'value': '40.5', 'spread': '31.4', 'groupId': 'OG003'}, {'value': '269', 'spread': '182', 'groupId': 'OG004'}, {'value': '84.0', 'spread': '58.8', 'groupId': 'OG005'}, {'value': '1538', 'spread': '1344', 'groupId': 'OG006'}, {'value': '41.4', 'spread': '49.1', 'groupId': 'OG007'}]}]}, {'title': '2nd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1922', 'spread': '825', 'groupId': 'OG000'}, {'value': '141.1', 'spread': '73.78', 'groupId': 'OG001'}, {'value': '1248', 'spread': '542', 'groupId': 'OG002'}, {'value': '32.2', 'spread': '19.8', 'groupId': 'OG003'}, {'value': '383', 'spread': '210', 'groupId': 'OG004'}, {'value': '54.3', 'spread': '25.8', 'groupId': 'OG005'}, {'value': '168', 'spread': '149', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Here, NA indicates that the data is not reported because the plasma concentrations were BQL (\\< 5.00 ng/mL).', 'groupId': 'OG007'}]}]}, {'title': '3rd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2661', 'spread': '1269', 'groupId': 'OG000'}, {'value': '148.1', 'spread': '52.26', 'groupId': 'OG001'}, {'value': '1075', 'spread': '594', 'groupId': 'OG002'}, {'value': '28.0', 'spread': '20.5', 'groupId': 'OG003'}, {'value': '349', 'spread': '103', 'groupId': 'OG004'}, {'value': '52.9', 'spread': '24.4', 'groupId': 'OG005'}, {'value': '184', 'spread': '99.0', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Here, NA indicates that the data is not reported because the plasma concentrations were BQL (\\< 5.00 ng/mL).', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The Cmin is the minimum observed plasma concentration.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG005', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG006', 'title': 'Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG007', 'title': 'Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Postpartum (6-12 W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6659', 'spread': '2364', 'groupId': 'OG000'}, {'value': '1110', 'spread': '901.2', 'groupId': 'OG001'}, {'value': '7310', 'spread': '1704', 'groupId': 'OG002'}, {'value': '742', 'spread': '335', 'groupId': 'OG003'}, {'value': '569', 'spread': '261', 'groupId': 'OG004'}, {'value': '167', 'spread': '101', 'groupId': 'OG005'}, {'value': '7918', 'spread': '2199', 'groupId': 'OG006'}, {'value': '996', 'spread': '323', 'groupId': 'OG007'}]}]}, {'title': '2nd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4668', 'spread': '1097', 'groupId': 'OG000'}, {'value': '546.8', 'spread': '249.4', 'groupId': 'OG001'}, {'value': '4964', 'spread': '1505', 'groupId': 'OG002'}, {'value': '439', 'spread': '241', 'groupId': 'OG003'}, {'value': '774', 'spread': '300', 'groupId': 'OG004'}, {'value': '121', 'spread': '45.9', 'groupId': 'OG005'}, {'value': '4340', 'spread': '1616', 'groupId': 'OG006'}, {'value': '571', 'spread': '350', 'groupId': 'OG007'}]}]}, {'title': '3rd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '5328', 'spread': '1631', 'groupId': 'OG000'}, {'value': '536.1', 'spread': '210.6', 'groupId': 'OG001'}, {'value': '5132', 'spread': '1198', 'groupId': 'OG002'}, {'value': '397', 'spread': '184', 'groupId': 'OG003'}, {'value': '785', 'spread': '238', 'groupId': 'OG004'}, {'value': '123', 'spread': '47.5', 'groupId': 'OG005'}, {'value': '4910', 'spread': '970', 'groupId': 'OG006'}, {'value': '759', 'spread': '366', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The Cmax is the maximum observed plasma concentration.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Time to Reach the Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG005', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG006', 'title': 'Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG007', 'title': 'Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Postpartum (6-12 W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '5.04', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '12.08'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '4.18', 'groupId': 'OG003', 'lowerLimit': '2.02', 'upperLimit': '6.03'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '9.00'}, {'value': '4.00', 'groupId': 'OG005', 'lowerLimit': '2.03', 'upperLimit': '25.08'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG007', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}, {'title': '2nd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '5.83'}, {'value': '4.17', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '6.08'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '6.08'}, {'value': '5.92', 'groupId': 'OG003', 'lowerLimit': '2.03', 'upperLimit': '6.10'}, {'value': '3.05', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '9.00'}, {'value': '4.00', 'groupId': 'OG006', 'lowerLimit': '3.00', 'upperLimit': '6.00'}, {'value': '4.03', 'groupId': 'OG007', 'lowerLimit': '2.00', 'upperLimit': '6.00'}]}]}, {'title': '3rd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '11.88'}, {'value': '4.07', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '9.10'}, {'value': '3.05', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '6.00', 'groupId': 'OG003', 'lowerLimit': '2.02', 'upperLimit': '6.02'}, {'value': '3.00', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '24.93'}, {'value': '3.50', 'groupId': 'OG006', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '3.50', 'groupId': 'OG007', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.', 'unitOfMeasure': 'hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Postpartum (6-12 W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56890', 'spread': '26340', 'groupId': 'OG000'}, {'value': '7406', 'spread': '6188', 'groupId': 'OG001'}, {'value': '5004', 'spread': '2521', 'groupId': 'OG002'}]}]}, {'title': '2nd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39370', 'spread': '9597', 'groupId': 'OG000'}, {'value': '3775', 'spread': '1265', 'groupId': 'OG001'}, {'value': '6617', 'spread': '2766', 'groupId': 'OG002'}]}]}, {'title': '3rd Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45880', 'spread': '17360', 'groupId': 'OG000'}, {'value': '3750', 'spread': '1336', 'groupId': 'OG001'}, {'value': '6846', 'spread': '1482', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Postpartum (6-12 W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '92116', 'spread': '29241', 'groupId': 'OG000'}, {'value': '6584', 'spread': '2861', 'groupId': 'OG001'}, {'value': '2714', 'spread': '1535', 'groupId': 'OG002'}, {'value': '99613', 'spread': '34862', 'groupId': 'OG003'}, {'value': '8643', 'spread': '3187', 'groupId': 'OG004'}]}]}, {'title': '2nd trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '62289', 'spread': '16234', 'groupId': 'OG000'}, {'value': '3935', 'spread': '2063', 'groupId': 'OG001'}, {'value': '1792', 'spread': '711', 'groupId': 'OG002'}, {'value': '47293', 'spread': '19058', 'groupId': 'OG003'}, {'value': '3862', 'spread': '2703', 'groupId': 'OG004'}]}]}, {'title': '3rd trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '61112', 'spread': '13790', 'groupId': 'OG000'}, {'value': '3821', 'spread': '1723', 'groupId': 'OG001'}, {'value': '1762', 'spread': '662', 'groupId': 'OG002'}, {'value': '47991', 'spread': '9879', 'groupId': 'OG003'}, {'value': '4736', 'spread': '2917', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg /Ritonavir 100 Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': '2nd trimester Less than(<)50 copies/milliLiter(mL)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': '3rd trimester: <50 copies/mL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Postpartum (2-5 weeks): <50 copies/mL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Postpartum (6-12 weeks): <50 copies/mL', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to postpartum (6-12 weeks)', 'description': 'Number of participants were assessed with a viral load (VL) lesser than (\\<) 50 HIV-1 RNA copies/ mL over time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg /Ritonavir 100 Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.12', 'spread': '0.179', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '2.06', 'spread': '0.206', 'groupId': 'OG002'}, {'value': '1.84', 'spread': '0.159', 'groupId': 'OG003'}, {'value': '1.77', 'spread': '0.283', 'groupId': 'OG004'}]}]}, {'title': '4 Weeks after Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.145', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.182', 'groupId': 'OG002'}, {'value': '0.20', 'spread': '0.172', 'groupId': 'OG003'}]}]}, {'title': '2nd trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.104', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '0.084', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '0.074', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.233', 'groupId': 'OG004'}]}]}, {'title': '3rd trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.105', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '0.113', 'groupId': 'OG003'}, {'value': '0.21', 'spread': '0.326', 'groupId': 'OG004'}]}]}, {'title': 'Postpartum (2-5 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.146', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.168', 'groupId': 'OG002'}, {'value': '0.20', 'spread': '0.273', 'groupId': 'OG003'}, {'value': '0.18', 'spread': '0.304', 'groupId': 'OG004'}]}]}, {'title': 'Postpartum (6-12 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.265', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.058', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '0.138', 'groupId': 'OG003'}, {'value': '0.23', 'spread': '0.347', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)', 'description': 'Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).', 'unitOfMeasure': 'Log 10 copies per milliliter (copies/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in CD4+ Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg /Ritonavir 100 Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '466.3', 'spread': '49.07', 'groupId': 'OG000'}, {'value': '497.9', 'spread': '64.60', 'groupId': 'OG001'}, {'value': '417.47', 'spread': '80.469', 'groupId': 'OG002'}, {'value': '495.79', 'spread': '79.322', 'groupId': 'OG003'}, {'value': '594.17', 'spread': '108.151', 'groupId': 'OG004'}]}]}, {'title': '4 Weeks after Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-14.8', 'spread': '23.16', 'groupId': 'OG000'}, {'value': '116.3', 'spread': '62.41', 'groupId': 'OG001'}, {'value': '6.25', 'spread': '26.004', 'groupId': 'OG002'}, {'value': '24.00', 'spread': '56.912', 'groupId': 'OG003'}]}]}, {'title': '2nd trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '37.1', 'spread': '23.31', 'groupId': 'OG000'}, {'value': '154.1', 'spread': '44.08', 'groupId': 'OG001'}, {'value': '13.77', 'spread': '53.225', 'groupId': 'OG002'}, {'value': '39.21', 'spread': '36.496', 'groupId': 'OG003'}, {'value': '13.29', 'spread': '34.445', 'groupId': 'OG004'}]}]}, {'title': '3rd trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '83.5', 'spread': '29.45', 'groupId': 'OG000'}, {'value': '274.9', 'spread': '65.41', 'groupId': 'OG001'}, {'value': '77.30', 'spread': '30.803', 'groupId': 'OG002'}, {'value': '89.46', 'spread': '26.137', 'groupId': 'OG003'}, {'value': '72.17', 'spread': '62.882', 'groupId': 'OG004'}]}]}, {'title': 'Postpartum (2-5 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '127.9', 'spread': '28.53', 'groupId': 'OG000'}, {'value': '186.0', 'spread': '43.51', 'groupId': 'OG001'}, {'value': '115.36', 'spread': '33.584', 'groupId': 'OG002'}, {'value': '139.42', 'spread': '36.972', 'groupId': 'OG003'}, {'value': '163', 'spread': '37.177', 'groupId': 'OG004'}]}]}, {'title': 'Postpartum (6-12 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '174.5', 'spread': '44.98', 'groupId': 'OG000'}, {'value': '323.0', 'spread': '63.99', 'groupId': 'OG001'}, {'value': '154.90', 'spread': '54.131', 'groupId': 'OG002'}, {'value': '168.18', 'spread': '41.345', 'groupId': 'OG003'}, {'value': '244.67', 'spread': '100.74', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)', 'description': 'Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.', 'unitOfMeasure': '10^6 Cells/Liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signified number of participants evaluated for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Resistance at Virological Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg /Ritonavir 100 Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to follow-up phase (16 weeks after postpartum)', 'description': 'Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (\\>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load \\>1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load \\>200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (\\<=) 200 copies/mL. For participants with a baseline viral load \\<=200 copies/mL, virologic failure was defined as viral load of \\>200 copies/mL (at 2 successive visits) at any point during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) orally twice daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Ritonavir 100 mg (Darunavir 600/Ritonavir 100 mg) Twice Daily', 'description': 'Participants received ritonavir 100 mg capsules orally twice daily along with darunavir 600 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Darunavir 800 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) orally once daily along with ritonavir 100 mg up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Ritonavir 100 mg (Darunavir 800/Ritonavir 100 mg) Once Daily', 'description': 'Participants received ritonavir 100 mg capsules orally once daily along with darunavir 800 mg tablets up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG005', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG006', 'title': 'Darunavir 800 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG007', 'title': 'Cobicistat 150 mg (Darunavir 800/Cobicistat 150 mg) Once Daily', 'description': 'Participants received cobicistat 150 mg along with darunavir 800 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Cord Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '348.4', 'spread': '322.90', 'groupId': 'OG000'}, {'value': '17.07', 'spread': '23.98', 'groupId': 'OG001'}, {'value': '228', 'spread': '302', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data was not analyzed in case either the cord or maternal plasma concentration was below quantification limit (lesser than (\\<) 5.00 ng/mL).', 'groupId': 'OG003'}, {'value': '147', 'spread': '61.3', 'groupId': 'OG004'}, {'value': '32.8', 'spread': '16.7', 'groupId': 'OG005'}, {'value': '125', 'spread': '106', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The data was not analyzed in case either the cord or maternal plasma concentration was below quantification limit (lesser than (\\<) 5.00 ng/mL).', 'groupId': 'OG007'}]}]}, {'title': 'Maternal Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2149', 'spread': '1140', 'groupId': 'OG000'}, {'value': '316.7', 'spread': '394.4', 'groupId': 'OG001'}, {'value': '1663', 'spread': '1691', 'groupId': 'OG002'}, {'value': '154', 'spread': '274', 'groupId': 'OG003'}, {'value': '421', 'spread': '157', 'groupId': 'OG004'}, {'value': '59.0', 'spread': '34.7', 'groupId': 'OG005'}, {'value': '857', 'spread': '885', 'groupId': 'OG006'}, {'value': '74.5', 'spread': '109', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On day of delivery - Intrapartum (Visit 6)', 'description': 'The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here 'N' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg /Ritonavir 100 Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Birth to age 16 weeks', 'description': 'The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).', 'unitOfMeasure': 'infants', 'reportingStatus': 'POSTED', 'populationDescription': "Infants population whose mothers were included in Intent-to-treat (ITT) analysis set and who were enrolled in this study and took at least one dose of study medication. 'N' signifies number of infants who were born and had HIV test data available."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Darunavir 600 mg /Ritonavir 100 Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'OG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'OG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'OG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to follow up period (16 weeks after postpartum)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Darunavir 600 mg /Ritonavir 100 mg Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'FG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'FG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'FG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'FG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Darunavir 600 mg /Ritonavir 100 mg Twice Daily', 'description': 'Participants received darunavir 600 milligram (mg) tablets (300\\*2) and ritonavir 100 mg capsules orally twice daily up to 12 weeks postpartum.'}, {'id': 'BG001', 'title': 'Darunavir 800 mg /Ritonavir 100 mg Once Daily', 'description': 'Participants received darunavir 800 mg tablets (400\\*2) and ritonavir 100 mg capsules orally once daily up to 12 weeks postpartum.'}, {'id': 'BG002', 'title': 'Etravirine 200 mg Twice Daily', 'description': 'Participants received etravirine 200 mg (1\\*200 mg/2\\*100 mg) tablets orally twice daily up to 12 weeks postpartum.'}, {'id': 'BG003', 'title': 'Rilpivirine 25 mg Once Daily', 'description': 'Participants received tablets containing 25 mg rilpivirine (EDURANT or COMPLERA) orally once daily up to 12 weeks postpartum.'}, {'id': 'BG004', 'title': 'Darunavir 800 mg/Cobicistat 150 mg Once Daily', 'description': 'Participants received darunavir 800 mg and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) orally once daily up to 12 weeks postpartum.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '24.2', 'spread': '3.45', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '4.91', 'groupId': 'BG002'}, {'value': '27.2', 'spread': '4.51', 'groupId': 'BG003'}, {'value': '28.86', 'spread': '4.71', 'groupId': 'BG004'}, {'value': '26.1', 'spread': '4.75', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-06', 'studyFirstSubmitDate': '2009-03-02', 'resultsFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-15', 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predose (Trough) Plasma Concentration (C0h)', 'timeFrame': 'Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.'}, {'measure': 'Minimum Plasma Concentration (Cmin)', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The Cmin is the minimum observed plasma concentration.'}, {'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The Cmax is the maximum observed plasma concentration.'}, {'measure': 'Time to Reach the Maximum Plasma Concentration (Tmax)', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)', 'timeFrame': 'Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)', 'description': 'The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)', 'timeFrame': 'Up to postpartum (6-12 weeks)', 'description': 'Number of participants were assessed with a viral load (VL) lesser than (\\<) 50 HIV-1 RNA copies/ mL over time.'}, {'measure': 'Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value', 'timeFrame': 'Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)', 'description': 'Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).'}, {'measure': 'Mean Change From Baseline in CD4+ Cell Count', 'timeFrame': 'Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)', 'description': 'Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.'}, {'measure': 'Number of Participants With Resistance at Virological Failure', 'timeFrame': 'Up to follow-up phase (16 weeks after postpartum)', 'description': 'Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (\\>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load \\>1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load \\>200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (\\<=) 200 copies/mL. For participants with a baseline viral load \\<=200 copies/mL, virologic failure was defined as viral load of \\>200 copies/mL (at 2 successive visits) at any point during the study.'}, {'measure': 'Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery', 'timeFrame': 'On day of delivery - Intrapartum (Visit 6)', 'description': 'The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.'}, {'measure': 'Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result', 'timeFrame': 'Birth to age 16 weeks', 'description': 'The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to follow up period (16 weeks after postpartum)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV-1', 'HIV', 'Pregnancy', 'Postpartum', 'Human immunodeficiency virus', 'PREZISTA', 'INTELENCE', 'NORVIR', 'TMC114', 'TMC125', 'darunavir', 'ritonavir', 'etravirine', 'rilpivirine', 'TMC278', 'Cobicistat', 'treatment experienced'], 'conditions': ['HIV', 'HIV Infections', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '29335895', 'type': 'DERIVED', 'citation': 'Osiyemi O, Yasin S, Zorrilla C, Bicer C, Hillewaert V, Brown K, Crauwels HM. Pharmacokinetics, Antiviral Activity, and Safety of Rilpivirine in Pregnant Women with HIV-1 Infection: Results of a Phase 3b, Multicenter, Open-Label Study. Infect Dis Ther. 2018 Mar;7(1):147-159. doi: 10.1007/s40121-017-0184-8. Epub 2018 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.', 'detailedDescription': "There are many biological changes that occur during pregnancy, some of which may affect the way HIV medications are absorbed, distributed and removed within the body. Some medications have been used for HIV treatment during pregnancy, but little is known about how pregnancy affects the class of drugs being used in this study. To participate in this study, patients must be receiving 600mg of TMC114 (darunavir) taken with 100mg ritonavir twice daily or 800mg of TMC114 (darunavir) with 100mg of ritonavir once daily or 800 mg of darunavir taken with 150mg of cobicistat taken once daily or 200mg of TMC125 (etravirine) (with or without darunavir/ ritonavir) taken twice daily or 25mg of TMC278 (rilpivirine) taken once daily plus additional antiretroviral drugs needed to construct an active antiretroviral regimen. Darunavir and ritonavir, darunavir and cobicistat, etravirine, or rilpivirine will be supplied to study participants. Darunavir and ritonavir are human immunodeficiency virus (HIV) protease inhibitors (PIs); cobicistat is a pharmacoenhancer which boosts the levels of darunavir but has no anti-HIV activity; etravirine and rilpivirine are non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV. Twelve-hour or twenty four-hour blood sampling will be done for each patient at each of three study visits: Visit 4 (2nd trimester), Visit 5 (3rd trimester), and Visit 8 (6-12 weeks postpartum). Eight blood draws will be taken during each visit: One prior to intake of study medication, and one for each of seven post-dose sampling time-points (hours 1, 2, 3, 4, 6, 9 and 12). The study is designed primarily to examine the pharmacokinetics of darunavir/ritonavir (darunavir/r), darunavir/ cobicistat, etravirine or rilpivirine during the second and third trimesters of gestation, as well as postpartum. Pharmacokinetics measures how the body absorbs, distributes and excretes medication. The study will also examine any changes in anti-viral activity during pregnancy, and the postpartum period. It will note any safety and tolerability of the medications used by the mother, and will measure the level of darunavir/ritonavir, darunavir/ cobicistat, etravirine or rilpivirine in the newborn's cord blood at the time of delivery; outcomes for both mother and child will be assessed as well. During the treatment period, patients will be seen at regular visits in the clinic, where the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits as well as blood pressure monitoring. Up to forty-eight (48) HIV positive pregnant women will participate in this study. Study enrollment will be closed once 12 evaluable patients taking darunavir/ritonavir once daily, 12 evaluable patients taking darunavir/cobicistat once daily, 12 evaluable patients taking darunavir/ritonavir twice daily, 12 evaluable patients taking etravirine taking twice daily and 12 evaluable patients taking rilpivirine once daily have been enrolled. The study will be conducted at approximately 14 research centers in the United States and 1 in Puerto Rico. In order to participate, patients must be pregnant for 13-24 weeks. The primary purpose (or outcome) of the study is to assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir, darunavir/ cobicistat, etravirine or rilpivirine during the second and third trimesters of gestation, as well as postpartum. Darunavir: One 600 mg or two 300 mg tablets taken twice daily by mouth (two or four tablets a day total). Ritonavir: 100mg tablet taken twice daily by mouth (two tablets a day total), together with darunavir. Darunavir: Two 400 mg tablets taken once daily by mouth (two tablets a day total). Ritonavir: 100mg tablet taken once daily by mouth (one tablet a day total), together with darunavir. Darunavir/ cobicistat: a fixed dose combination containing 800mg of darunavir and 150mg of cobicistat. Etravirine: Two 100 mg tablets taken twice daily by mouth (four tablets a day total). Rilpivirine: One 25mg tablet taken once daily by mouth (one tablet a day total). Study medication will be given from the baseline visit (second pregnancy trimester) until Visit 8 (up to 12 weeks after delivery)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females (18-26 weeks of gestation)\n* documented HIV-1 infection\n* Receiving darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine at the time of study entry\n* Willing to remain on darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine as well as a background regimen, for the duration of the study, including 12 weeks postpartum\n* Able to comply with the protocol requirements and to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with any currently active acquired immune deficiency syndrome (AIDS) defining illness and AIDS-related opportunistic infection\n* Patients using cytokine inhibitors (e.g., thalidomide), anabolic hormones, cytokines (e.g., IL-2, INF), efavirenz, hydroxyurea, oral hypoglycemics, systemic chemotherapy or known teratogenic agent\n* Use of an investigational agent within 90 days\n* Any known fetal anomaly\n* Any current obstetric complication, including multiple gestations and pre-term labor\n* Hepatitis B and/or C virus infection\n* Grade 2 or higher anemia\n* Thyroid disease\n* Uncontrolled Diabetes Mellitus Types I and II, or gestational diabetes, as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT00855335', 'briefTitle': 'A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Scientific Affairs, LLC'}, 'officialTitle': 'A Single Arm, Open Label Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women', 'orgStudyIdInfo': {'id': 'CR015442'}, 'secondaryIdInfos': [{'id': 'TMC114HIV3015', 'type': 'OTHER', 'domain': 'Janssen Scientific Affairs, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Darunavir 600 /Ritonavir 100', 'description': 'TMC114 (darunavir) Two 300 milligram (mg) or one 600 mg tablet twice daily up to 12 weeks postpartum / ritonavir one 100 mg tablet twice daily with darunavir up to 12 weeks postpartum.', 'interventionNames': ['Drug: Darunavir', 'Drug: Ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Darunavir 800/Ritonavir 100', 'description': 'TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum/ ritonavir one 100 mg tablet once daily with darunavir up to 12 weeks postpartum.', 'interventionNames': ['Drug: Darunavir', 'Drug: Ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Etravirine', 'description': 'TMC125 (etravirine) 200 mg (1\\*200 mg/2\\*100 mg) tablets twice daily up to 12 weeks postpartum.', 'interventionNames': ['Drug: Etravirine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Rilpivirine', 'description': 'TMC278 (rilpivirine) One 25 mg tablet once daily up to 12 weeks postpartum.', 'interventionNames': ['Drug: Rilpivirine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: Darunavir 800/Cobicistat 150', 'description': 'Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum.', 'interventionNames': ['Drug: Darunavir/Cobicistat (FDC)']}], 'interventions': [{'name': 'Darunavir', 'type': 'DRUG', 'description': 'TMC114 (darunavir) two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum in Group 1. TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum in Group 2.', 'armGroupLabels': ['Group 1: Darunavir 600 /Ritonavir 100', 'Group 2: Darunavir 800/Ritonavir 100']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': '100 mg tablet twice daily up to 12 weeks postpartum.', 'armGroupLabels': ['Group 1: Darunavir 600 /Ritonavir 100', 'Group 2: Darunavir 800/Ritonavir 100']}, {'name': 'Etravirine', 'type': 'DRUG', 'description': '200 mg (1\\*200 mg/2\\*100 mg) tablets twice daily up to 12 weeks postpartum.', 'armGroupLabels': ['Group 3: Etravirine']}, {'name': 'Rilpivirine', 'type': 'DRUG', 'description': 'One 25 mg tablet once daily up to 12 weeks postpartum.', 'armGroupLabels': ['Group 4: Rilpivirine']}, {'name': 'Darunavir/Cobicistat (FDC)', 'type': 'DRUG', 'description': 'Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum.', 'armGroupLabels': ['Group 5: Darunavir 800/Cobicistat 150']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'city': 'San Juan Pr', 'country': 'Puerto Rico'}], 'overallOfficials': [{'name': 'Janssen Scientific Affairs, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Scientific Affairs, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}