Viewing Study NCT02121795

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Ignite Creation Date: 2025-12-24 @ 1:33 PM
Ignite Modification Date: 2026-01-28 @ 11:03 AM
Study NCT ID: NCT02121795
Status: COMPLETED
Last Update Posted: 2020-03-12
First Post: 2014-04-22
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'C000613801', 'term': 'emtricitabine tenofovir alafenamide'}], 'ancestors': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': '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', 'phone': '1-833-445-3230', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations affecting the analysis or results.'}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug to the last dose (maximum: 227.4 weeks) plus 30 days', 'description': 'The Safety Analysis Set included all randomized participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'F/TAF + 3rd Agent (Double-Blind)', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg tablet) + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks.', 'otherNumAtRisk': 333, 'deathsNumAtRisk': 333, 'otherNumAffected': 242, 'seriousNumAtRisk': 333, 'deathsNumAffected': 2, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'FTC/TDF + 3rd Agent (Double-Blind)', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.', 'otherNumAtRisk': 330, 'deathsNumAtRisk': 330, 'otherNumAffected': 226, 'seriousNumAtRisk': 330, 'deathsNumAffected': 1, 'seriousNumAffected': 31}, {'id': 'EG002', 'title': 'Open-Label F/TAF From F/TAF', 'description': 'Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the F/TAF + 3rd Agent group.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 12, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Open-Label F/TAF From FTC/TDF', 'description': 'Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the FTC/TDF + 3rd Agent group.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 13, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Intestinal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Cholelithiasis obstructive', 'stats': [{'groupId': 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'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 333, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '93.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.002', 'paramValue': '1.3', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '5.1', 'estimateComment': 'Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.', 'nonInferiorityComment': 'Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.'}], '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 participant's virologic response 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': 'The Full Analysis Set included all participants who were randomized into the study and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.236', 'spread': '2.6602', 'groupId': 'OG000'}, {'value': '-0.071', 'spread': '2.3316', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'description': 'Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Hip DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline hip BMD data) with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Spine BMD at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.662', 'spread': '3.1279', 'groupId': 'OG000'}, {'value': '-0.109', 'spread': '3.3476', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'description': 'Spine BMD was assessed by DXA scan.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Spine DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline spine BMD data) with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '161.8', 'groupId': 'OG000'}, {'value': '21', 'spread': '152.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with on-treatment data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.5', 'groupId': 'OG000'}, {'value': '86.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '89.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Hip BMD at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.856', 'spread': '3.2195', 'groupId': 'OG000'}, {'value': '-0.289', 'spread': '2.9912', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 96', 'description': 'Hip BMD was assessed by DXA scan.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Hip DXA Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Spine BMD at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.159', 'spread': '3.8374', 'groupId': 'OG000'}, {'value': '-0.109', 'spread': '3.6738', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 96', 'description': 'Spine BMD was assessed by DXA scan.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Spine DXA Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'OG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '198.7', 'groupId': 'OG000'}, {'value': '46', 'spread': '169.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 96', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with on-treatment data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.\n\nOpen-Label Phase: After Week 96, participants continued to take their blinded study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program.'}, {'id': 'FG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.\n\nOpen-Label Phase: After Week 96, participants continued to take their blinded study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program.'}], 'periods': [{'title': 'Double-Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '334'}, {'groupId': 'FG001', 'numSubjects': '334'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}, {'groupId': 'FG001', 'numSubjects': '330'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not all participants entered the Open-Label Phase.', 'groupId': 'FG000', 'numSubjects': '33'}, {'comment': 'Not all participants entered the Open-Label Phase.', 'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America and Europe. The first participant was screened on 06 May 2014. The last study visit occurred on 1 March 2019.', 'preAssignmentDetails': '780 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '663', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'F/TAF + 3rd Agent', 'description': 'Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'BG001', 'title': 'FTC/TDF + 3rd Agent', 'description': 'Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '48', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '48', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '561', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '537', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '497', 'groupId': 'BG002'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '556', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Third Agent', 'classes': [{'title': 'Atazanavir boosted with ritonavir (ATV/r)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Darunavir boosted with ritonavir (DRV/r)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': 'Lopinavir boosted with ritonavir (LPV/r)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Dolutegravir (DTG)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Efavirenz (EFV)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Maraviroc (MVC)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Nevirapine (NVP)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'Raltegravir (RAL)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Rilpivirine (RPV)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HIV-1 RNA Categories', 'classes': [{'title': '< 50 copies/mL', 'categories': [{'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}, {'title': '>= 50 copies/mL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '691', 'spread': '272.6', 'groupId': 'BG000'}, {'value': '667', 'spread': '272.3', 'groupId': 'BG001'}, {'value': '679', 'spread': '272.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Analysis Set included all randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 668}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2014-04-22', 'resultsFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-07', 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis', '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 participant's virologic response 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 Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48', 'timeFrame': 'Baseline; Week 48', 'description': 'Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.'}, {'measure': 'Percentage Change From Baseline in Spine BMD at Week 48', 'timeFrame': 'Baseline; Week 48', 'description': 'Spine BMD was assessed by DXA scan.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis', 'timeFrame': 'Week 48', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 48', 'timeFrame': 'Baseline; Week 48'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis', 'timeFrame': 'Week 96', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis', 'timeFrame': 'Week 96', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Percentage Change From Baseline in Hip BMD at Week 96', 'timeFrame': 'Baseline; Week 96', 'description': 'Hip BMD was assessed by DXA scan.'}, {'measure': 'Percentage Change From Baseline in Spine BMD at Week 96', 'timeFrame': 'Baseline; Week 96', 'description': 'Spine BMD was assessed by DXA scan.'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 96', 'timeFrame': 'Baseline; Week 96'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'HIV-1 Positive', 'Virologically-suppressed'], 'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '27036991', 'type': 'DERIVED', 'citation': 'Gallant JE, Daar ES, Raffi F, Brinson C, Ruane P, DeJesus E, Johnson M, Clumeck N, Osiyemi O, Ward D, Morales-Ramirez J, Yan M, Abram ME, Plummer A, Cheng AK, Rhee MS. Efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate given as fixed-dose combinations containing emtricitabine as backbones for treatment of HIV-1 infection in virologically suppressed adults: a randomised, double-blind, active-controlled phase 3 trial. Lancet HIV. 2016 Apr;3(4):e158-65. doi: 10.1016/S2352-3018(16)00024-2. Epub 2016 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF.\n\nThis study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.'}, '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, which must be obtained prior to initiation of study procedures\n* Currently receiving antiretroviral regimen containing FTC/TDF in combination with one third agent for ≥ 6 consecutive months prior to screening.\n* Plasma HIV-1 RNA levels \\< 50 copies/mL for at least 6 months preceding the screening visit (measured at least twice using the same assay) and not experienced two consecutive HIV-1 RNA above detectable levels after achieving a confirmed (two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year.\n* Plasma HIV-1 RNA should be \\< 50 copies/mL at the screening visit.\n* Normal electrocardiogram (ECG)\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × the upper limit of the normal range (ULN)\n* Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (individuals with documented Gilbert's syndrome or with Atazanavir-associated hyperbilirubinemia may have total bilirubin up to 5 x ULN)\n* Adequate hematologic function\n* Serum amylase ≤ 5 × ULN\n* Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active, or practice abstinence from screening throughout the duration of the study treatment and for 30 days following the last dose of the study drug.\n* Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range.\n* Females 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* Males 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\nKey Exclusion Criteria:\n\n* A new AIDS-defining condition diagnosed within the 30 days prior to screening\n* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable\n* Individuals experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)\n* Individuals receiving ongoing treatment with bisphosphonate to treat bone disease (eg, osteoporosis)\n* Females who are breastfeeding\n* Positive serum pregnancy test\n* Have an implanted defibrillator or pacemaker\n* Current alcohol or substance use judged by the investigator to potentially interfere with study compliance\n* A history of malignancy within the past 5 years (prior to screening) 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* Individuals receiving ongoing therapy with any of the medications not to be used with FTC, TAF, TDF or other antiretroviral third agents.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT02121795', 'briefTitle': 'Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF', 'orgStudyIdInfo': {'id': 'GS-US-311-1089'}, 'secondaryIdInfos': [{'id': '2013-005138-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F/TAF + 3rd Agent', 'description': "Participants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen.", 'interventionNames': ['Drug: F/TAF', 'Drug: Allowed third antiretroviral agent', 'Drug: FTC/TDF Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FTC/TDF + 3rd Agent', 'description': "Participants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks.", 'interventionNames': ['Drug: FTC/TDF', 'Drug: Allowed third antiretroviral agent', 'Drug: F/TAF Placebo']}], 'interventions': [{'name': 'FTC/TDF', 'type': 'DRUG', 'otherNames': ['Truvada®'], 'description': '200/300 mg FDC tablets administered orally once daily', 'armGroupLabels': ['FTC/TDF + 3rd Agent']}, {'name': 'F/TAF', 'type': 'DRUG', 'otherNames': ['Descovy®'], 'description': 'Tablets administered orally once daily', 'armGroupLabels': ['F/TAF + 3rd Agent']}, {'name': 'Allowed third antiretroviral agent', 'type': 'DRUG', 'description': "An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).", 'armGroupLabels': ['F/TAF + 3rd Agent', 'FTC/TDF + 3rd Agent']}, {'name': 'FTC/TDF Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally once daily', 'armGroupLabels': ['F/TAF + 3rd Agent']}, {'name': 'F/TAF Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally once daily', 'armGroupLabels': ['FTC/TDF + 3rd Agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Spectrum Medical Group', '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': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tarrant County ID Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Southern California Men's Medical Group", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Highland Hospital - Alameda Health System (formerly Alameda County medical Center)', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Sacramento Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'La Playa Medical Group and Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Medical Group San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Apex Research LLC', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'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': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman-Walker Health', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Capital Medical Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'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. 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