Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01968551
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2013-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
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': 'D000069545', 'term': 'Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000069547', 'term': 'Cobicistat'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to a maximum of 97.4 weeks (duration of exposure: Cohort 1 and Cohort 2 = 48 weeks; All E/C/F/TAF = up to maximum of 97.4 weeks)', 'description': 'Safety Analysis Set included all participants in:\n\n* Cohort 1: who were enrolled into Cohort 1 and received at least 1 dose of study drug during the open-label Phase\n* Cohort 2: who were randomized into Cohort 2 and received at least 1 dose of study drug during the open-label Phase\n* All E/C/F/TAF: who received at least 1 dose of E/C/F/TAF during the Open-Label Phase or Extension Phase\n\nFor Cohort 1 and Cohort 2, only the adverse events that occurred during the Open-Label Phase are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily', 'otherNumAtRisk': 21, 'otherNumAffected': 13, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily', 'otherNumAtRisk': 89, 'otherNumAffected': 56, 'seriousNumAtRisk': 89, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Cohort 2: SBR', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily', 'otherNumAtRisk': 46, 'otherNumAffected': 28, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'All E/C/F/TAF', 'description': 'Open- label or Extension Phase: All participants received E/C/F/TAF.', 'otherNumAtRisk': 144, 'otherNumAffected': 104, 'seriousNumAtRisk': 144, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gastroenteritis clostridial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'OG001', 'title': 'Cohort 2: Stay on Baseline Regimen (SBR)', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000'}, {'value': '91.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.001', 'paramValue': '5.3', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '17.4', 'estimateComment': 'Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA\\<50 copies/mL at Week 24.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the open-label Phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'OG001', 'title': 'Cohort 2: Stay on Baseline Regimen (SBR)', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '76.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.001', 'paramValue': '18.3', 'ciLowerLimit': '3.5', 'ciUpperLimit': '33.0', 'estimateComment': 'Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA \\< 50 copies/mL at Week 48.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'OG001', 'title': 'Cohort 2: Stay on Baseline Regimen (SBR)', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '155.2', 'groupId': 'OG000'}, {'value': '12', 'spread': '100.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'OG001', 'title': 'Cohort 2: Stay on Baseline Regimen (SBR)', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.\n\nOpen-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '162.6', 'groupId': 'OG000'}, {'value': '41', 'spread': '104.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: E/C/F/TAF+DRV', 'description': 'Open-Label (OL) Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily'}, {'id': 'FG001', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'FG002', 'title': 'Cohort 2: Stay on Baseline Regimen (SBR)', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks.\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}], 'periods': [{'title': 'Open Label Phase (48 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'comment': '7 participant completed the Open-Label Phase, but did not enter in the Extension Phase', 'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 3 September 2013. The last study visit occurred on 09 July 2016.', 'preAssignmentDetails': '231 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'BG001', 'title': 'Cohort 2: E/C/F/TAF+DRV', 'description': 'Open-Label Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'BG002', 'title': 'Cohort 2: SBR', 'description': 'Open-Label Phase: Participants stayed on their baseline DRV- containing regimen administered according to the prescribing information for up to 48 weeks\n\nOpen-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '49', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '47', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '49', 'spread': '8.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA Category', 'classes': [{'title': '< 50 copies/mL', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}]}]}, {'title': '≥ 50 copies/mL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '700', 'spread': '372.5', 'groupId': 'BG000'}, {'value': '562', 'spread': '260.8', 'groupId': 'BG001'}, {'value': '571', 'spread': '245.2', 'groupId': 'BG002'}, {'value': '583', 'spread': '275.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Cell Count Category', 'classes': [{'title': '< 200 cells/µL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': '≥ 200 to < 350 cells/µL', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': '≥ 350 cells/µL', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety analysis set included:\n\n* Cohort 1: participants who (1) were enrolled into Cohort 1 and (2) received at least 1 dose of study drug during the OL Phase or the Extension Phase\n* Cohort 2: participants who (1) were randomized into Cohort 2 and (2) received at least 1 dose of study drug during the OL Phase or the Extension Phase'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2015-04-16', 'completionDateStruct': {'date': '2016-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2013-09-26', 'dispFirstSubmitQcDate': '2015-04-16', 'resultsFirstSubmitDate': '2016-07-20', 'studyFirstSubmitQcDate': '2013-10-18', 'dispFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-14', 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24', 'timeFrame': 'Week 24', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48', 'timeFrame': 'Week 48', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 24', 'timeFrame': 'Baseline; Week 24'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 48', 'timeFrame': 'Baseline; Week 48'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV-1', 'HIV', 'Treatment-Experienced'], 'conditions': ['HIV-1', 'HIV Infections', 'Acquired Immunodeficiency Syndrome']}, 'referencesModule': {'references': [{'pmid': '27753684', 'type': 'BACKGROUND', 'citation': 'Huhn GD, Tebas P, Gallant J, Wilkin T, Cheng A, Yan M, Zhong L, Callebaut C, Custodio JM, Fordyce MW, Das M, McCallister S. A Randomized, Open-Label Trial to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Darunavir in Treatment-Experienced HIV-1-Infected Adults. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):193-200. doi: 10.1097/QAI.0000000000001193.'}, {'type': 'BACKGROUND', 'citation': 'Greg Huhn, Pablo Tebas, Joel Gallant et al. Strategic Simplification: the Efficacy and Safety of Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Plus Darunavir (DRV) in Treatment-Experienced HIV-1-Infected Adults (NCT01968551). IDWeek; 2015 San Diego, CA Oct. 7-11.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \\<50 copies/mL at Week 24.\n\nThis study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent form\n* History of at least two prior antiretroviral regimens, and history of resistance to at least two different classes of antiretroviral agents\n* Plasma HIV-1 RNA levels \\< 50 copies/mL at screening. Virologically suppressed on the current antiretroviral regimen containing darunavir 600 mg twice a day or 800 mg once daily continuously for ≥ 4 months preceding the screening visit and have maintained documented undetectable plasma HIV-1 RNA levels (\\< 50 copies/mL) and must have documentation of genotype/phenotype prior to current regimen which shows no darunavir associated resistance mutation.\n* Currently receiving raltegravir, elvitegravir, or dolutegravir (50 mg once daily, but not twice daily), or have never received integrase inhibitor, or have documentation of genotype/phenotype within 12 months prior to current regimen which must show no evidence of resistance to integrase inhibitors\n* Normal ECG\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft Gault formula for creatinine clearance\n* Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin\n* Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\\^3; platelets ≥ 50,000/mm\\^3; hemoglobin ≥ 8.5 g/dL)\n* Serum amylase ≤ 5 × ULN (individuals with serum amylase \\> 5 × ULN will remain eligible if serum lipase is ≤ 5 × ULN)\n* A female individual is eligible to enter the study if it is confirmed that she is:\n\n * Not pregnant or nursing\n * Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women \\> 54 years of age with cessation (for ≥ 12 months) of previously occurring menses), or\n * Of childbearing potential and agrees to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last study drug dose.\n * Female individuals who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.\n* Male individuals must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.\n* Male individuals must agree to refrain from sperm donation from first dose until at least 30 days after the last study drug dose.\n\nKey Exclusion Criteria:\n\n* A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4 cell count and/or percentage criteria)\n* Hepatitis B surface antigen (HBsAg) positive\n* Individuals receiving drug treatment for Hepatitis C, or individuals who are anticipated to receive treatment for Hepatitis C during the course of the study.\n* Must not have Q151M, T69ins, or \\> 3 thymidine analogue mutations (TAMS) present on documented historic genotype report\n* Individuals experiencing decompensated cirrhosis\n* Females who are breastfeeding\n* Positive serum pregnancy test\n* Have an implanted defibrillator or pacemaker\n* Current alcohol or substance use that may interfere with individual's study compliance\n* A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.\n* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1 visit\n* Any other clinical condition or prior therapy that would make the individual unsuitable for the study or unable to comply with dosing requirements\n* Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial\n* Individuals receiving ongoing therapy with any of the disallowed medications, including drugs not to be used with elvitegravir, cobicistat, emtricitabine, TAF, or DRV; or individuals with any known allergies to the study drugs.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01968551', 'briefTitle': 'Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults', 'orgStudyIdInfo': {'id': 'GS-US-292-0119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants will receive E/C/F/TAF FDC + DRV once daily with food for 48 weeks.\n\nBased on safety and efficacy data from Cohort 1 at Week 4, the participants will be randomized into Cohort 2. The participants in Cohort 1 will continue receiving E/C/F/TAF FDC + DRV through 48 weeks.', 'interventionNames': ['Drug: E/C/F/TAF', 'Drug: DRV']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, Treatment Group 1', 'description': 'Participants will be randomized to receive E/C/F/TAF FDC+DRV once daily with food for 48 weeks.', 'interventionNames': ['Drug: E/C/F/TAF', 'Drug: DRV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2, Treatment Group 2', 'description': 'Participants will be randomized to continue on their baseline DRV-containing ARV regimen for 48 weeks.', 'interventionNames': ['Drug: Baseline DRV- containing ARV regimen']}], 'interventions': [{'name': 'E/C/F/TAF', 'type': 'DRUG', 'otherNames': ['Genvoya®'], 'description': '150/150/200/10 mg FDC tablet administered orally once daily', 'armGroupLabels': ['Cohort 1', 'Cohort 2, Treatment Group 1']}, {'name': 'DRV', 'type': 'DRUG', 'description': '800 mg tablet administered orally once daily', 'armGroupLabels': ['Cohort 1', 'Cohort 2, Treatment Group 1']}, {'name': 'Baseline DRV- containing ARV regimen', 'type': 'DRUG', 'description': 'Participants will take their baseline DRV- containing ARV regimen as prescribed.', 'armGroupLabels': ['Cohort 2, Treatment Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pueblo Family Physicians, Ltd.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Oaks Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94545', 'city': 'Hayward', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 37.66882, 'lon': -122.0808}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Education and Research Consultants', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Peter J Ruane, MD, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser San Francisco Division of Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Dupont Circle Physician's Group", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Midland Florida Clinical Research Center, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Therafirst Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Gary J.Richmond, MD, P.A.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'Midway Immunology and Research Center', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Immunology Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Valuhealthmd/Idocf', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Infectious Diseases Associates of NW FL', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Hillsborough County Health Department', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Comprehensive Research Institute", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'AIDS Research and Treatment Center of the Treasure Coast', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute PA', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta ID Group', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Mercer University, Mercer Medicine', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Ruth M. 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{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Kansas City Free Health Clinic/ KC Care Clinic', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Central West Clinical Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Infectious Disease', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 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