Viewing Study NCT02397694

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Ignite Creation Date: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2026-03-02 @ 7:44 AM
Study NCT ID: NCT02397694
Status: COMPLETED
Last Update Posted: 2020-04-07
First Post: 2015-03-20
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
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': 'C100119', 'term': 'imidazole mustard'}, {'id': 'C000620396', 'term': 'bictegravir'}, {'id': 'C562325', 'term': 'dolutegravir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', '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}}, 'adverseEventsModule': {'timeFrame': 'First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days', 'description': 'The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'BIC + F/TAF (Double-Blind Randomized)', 'description': 'Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to BIC + F/TAF. Participants received BIC (75 mg) + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 44, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'DTG + F/TAF (Double Blind Randomized):', 'description': 'Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to DTG + FTC/TAF. Participants received DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 18, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BIC + F/TAF to B/F/TAF (Open-Label Phase)', 'description': 'Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the BIC + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 42, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'DTG + F/TAF to B/F/TAF (Open-Label Phase)', 'description': 'Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the DTG + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 23, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Gonorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Proctitis gonococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Exposure to communicable disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Substance-induced psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Bladder mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '14.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs \\> 100,000 copies/mL).', 'nonInferiorityComment': 'Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%'}], '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 participant'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 all participants who were randomized into the double-blinded phase of study and received at least 1 dose of study drug during the double-blinded phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}, {'value': '93.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant'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': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}], '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 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': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in log10 HIV-1 RNA at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.03', 'spread': '0.791', 'groupId': 'OG000'}, {'value': '-3.15', 'spread': '0.731', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in log10 HIV-1 RNA at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.09', 'spread': '0.740', 'groupId': 'OG000'}, {'value': '-3.12', 'spread': '0.757', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in log10 HIV-1 RNA at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.09', 'spread': '0.752', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '0.852', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '170', 'spread': '150.0', 'groupId': 'OG000'}, {'value': '173', 'spread': '220.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'unitOfMeasure': 'CD4 Cell Count (/μL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in CD4+ Cell Count at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '190', 'spread': '176.8', 'groupId': 'OG000'}, {'value': '155', 'spread': '165.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'unitOfMeasure': 'CD4 Cell Count (/μL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '258', 'spread': '221.7', 'groupId': 'OG000'}, {'value': '188', 'spread': '238.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 48', 'unitOfMeasure': 'CD4 Cell Count (/μL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).'}], 'classes': [{'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'title': 'BIC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9344.3', 'spread': '2506.33', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants did not receive BIC', 'groupId': 'OG001'}]}]}, {'title': 'FTC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1919.1', 'spread': '470.18', 'groupId': 'OG000'}, {'value': '2157.1', 'spread': '486.44', 'groupId': 'OG001'}]}]}, {'title': 'TAF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249.1', 'spread': '137.40', 'groupId': 'OG000'}, {'value': '260.8', 'spread': '212.44', 'groupId': 'OG001'}]}]}, {'title': 'TFV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '8.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'Cmax is the maximum observed plasma concentration of the drug.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Substudy Analysis Set included all participants who (1) were randomized into the double-blinded phase of study, (2) were enrolled into the PK substudy, (3) received at least 1 dose of study drug during the double-blinded phase, and (4) had at least 1 nonmissing intensive PK concentration value.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'title': 'BIC', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '3.00'}, {'value': 'NA', 'comment': 'Participants did not receive BIC', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FTC', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '2.00'}]}]}, {'title': 'TAF', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.00'}]}]}, {'title': 'TFV', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '2.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.53', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'Tmax was defined as the time to Cmax.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Substudy Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'PK Parameter:Ctau for BIC, FTC and TFV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'title': 'BIC', 'categories': [{'measurements': [{'value': '3508.6', 'spread': '1288.85', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants did not receive BIC', 'groupId': 'OG001'}]}]}, {'title': 'FTC', 'categories': [{'measurements': [{'value': '76.6', 'spread': '26.35', 'groupId': 'OG000'}, {'value': '102.6', 'spread': '57.60', 'groupId': 'OG001'}]}]}, {'title': 'TFV', 'categories': [{'measurements': [{'value': '10.7', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '5.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'Ctau was defined as the observed drug concentration at the end of the dosing interval.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Substudy Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: AUCtau for BIC, FTC, TAF, and TFV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'title': 'BIC', 'categories': [{'measurements': [{'value': '139778.8', 'spread': '37810.07', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants did not receive BIC', 'groupId': 'OG001'}]}]}, {'title': 'FTC', 'categories': [{'measurements': [{'value': '11605.4', 'spread': '3241.84', 'groupId': 'OG000'}, {'value': '14689.8', 'spread': '5869.37', 'groupId': 'OG001'}]}]}, {'title': 'TAF', 'categories': [{'measurements': [{'value': '247.4', 'spread': '140.62', 'groupId': 'OG000'}, {'value': '245.6', 'spread': '125.03', 'groupId': 'OG001'}]}]}, {'title': 'TFV', 'categories': [{'measurements': [{'value': '316.0', 'spread': '74.01', 'groupId': 'OG000'}, {'value': '369.4', 'spread': '147.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'AUCtau is defined as the area under the concentration-time curve of the drug over time.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Substudy Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'PK Parameter: t1/2 of BIC, FTC, TAF, and TFV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}], 'classes': [{'title': 'BIC', 'categories': [{'measurements': [{'value': '16.73', 'groupId': 'OG000', 'lowerLimit': '13.79', 'upperLimit': '19.28'}, {'value': 'NA', 'comment': 'Participants did not receive BIC', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'FTC', 'categories': [{'measurements': [{'value': '5.46', 'groupId': 'OG000', 'lowerLimit': '5.19', 'upperLimit': '6.11'}, {'value': '5.70', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '6.38'}]}]}, {'title': 'TAF', 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '0.28', 'upperLimit': '0.49'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '0.45'}]}]}, {'title': 'TFV', 'categories': [{'measurements': [{'value': '37.74', 'groupId': 'OG000', 'lowerLimit': '28.26', 'upperLimit': '48.40'}, {'value': '34.47', 'groupId': 'OG001', 'lowerLimit': '31.97', 'upperLimit': '47.57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 't1/2 was defined as the terminal elimination half-life of the drug', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK Substudy Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIC + F/TAF', 'description': 'Bictegravir (BIC) (75 mg) + emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) + dolutegravir (DTG) placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'FG001', 'title': 'DTG + F/TAF', 'description': 'DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}], 'periods': [{'title': 'Double-Blinded Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open Label Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 22 centers in the United States of America.The first participant was screened on 23 March 2015 and the last study visit occurred on 27 February 2019.', 'preAssignmentDetails': '125 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BIC + F/TAF', 'description': 'BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).'}, {'id': 'BG001', 'title': 'DTG + F/TAF', 'description': 'DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '38', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '35', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA', 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '0.764', 'groupId': 'BG000'}, {'value': '4.38', 'spread': '0.866', 'groupId': 'BG001'}, {'value': '4.39', 'spread': '0.795', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV-1 RNA category', 'classes': [{'categories': [{'title': '≤ 100,000 copies/mL', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '> 100,000 to ≤ 400,000 copies/mL', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '> 400,000 copies/mL', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '471', 'spread': '190.9', 'groupId': 'BG000'}, {'value': '507', 'spread': '271.0', 'groupId': 'BG001'}, {'value': '483', 'spread': '220.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Cell Count Category', 'classes': [{'categories': [{'title': '< 200 cells/μL', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '≥ 200 to < 350 cells/µL', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '≥ 350 to < 500 cells/µL', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '≥ 500 cells/µL', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'dispFirstSubmitDate': '2016-08-22', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2015-03-20', 'dispFirstSubmitQcDate': '2016-08-22', 'resultsFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2015-03-20', 'dispFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-27', 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.', '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 participant'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 With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12', 'timeFrame': 'Week 12', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant'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': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm 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 participant'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': 'The Change From Baseline in log10 HIV-1 RNA at Week 12', 'timeFrame': 'Baseline; Week 12'}, {'measure': 'The Change From Baseline in log10 HIV-1 RNA at Week 24', 'timeFrame': 'Baseline; Week 24'}, {'measure': 'The Change From Baseline in log10 HIV-1 RNA at Week 48', 'timeFrame': 'Baseline; Week 48'}, {'measure': 'The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12', 'timeFrame': 'Baseline; Week 12'}, {'measure': 'The Change From Baseline in CD4+ Cell Count at Week 24', 'timeFrame': 'Baseline; Week 24'}, {'measure': 'The Change From Baseline in CD4+ Cell Count at Week 48', 'timeFrame': 'Baseline; Week 48'}, {'measure': 'Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase', 'timeFrame': 'First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)'}, {'measure': 'Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase', 'timeFrame': 'First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)'}, {'measure': 'PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'Cmax is the maximum observed plasma concentration of the drug.'}, {'measure': 'PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'Tmax was defined as the time to Cmax.'}, {'measure': 'PK Parameter:Ctau for BIC, FTC and TFV', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'Ctau was defined as the observed drug concentration at the end of the dosing interval.'}, {'measure': 'PK Parameter: AUCtau for BIC, FTC, TAF, and TFV', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 'AUCtau is defined as the area under the concentration-time curve of the drug over time.'}, {'measure': 'PK Parameter: t1/2 of BIC, FTC, TAF, and TFV', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8', 'description': 't1/2 was defined as the terminal elimination half-life of the drug'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adult', 'HIV', 'naive'], 'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '28219610', 'type': 'RESULT', 'citation': 'Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.'}, {'pmid': '29794828', 'type': 'RESULT', 'citation': 'Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Wei X, Collins SE, Cheng A. Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. AIDS. 2018 Jul 31;32(12):1723-1725. doi: 10.1097/QAD.0000000000001894.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)\n* Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening\n* Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)\n* Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula\n* CD4+ cell count ≥ 200 cells/µL at screening\n\nKey Exclusion Criteria:\n\n* A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol\n* Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)\n* Chronic hepatitis B virus (HBV) infection\n* Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)\n* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline\n* Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02397694', 'briefTitle': 'Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults', 'orgStudyIdInfo': {'id': 'GS-US-141-1475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIC + F/TAF', 'description': 'Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.\n\n* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.', 'interventionNames': ['Drug: BIC', 'Drug: F/TAF', 'Drug: DTG Placebo', 'Drug: B/F/TAF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DTG + F/TAF', 'description': 'Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.\n\n* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.', 'interventionNames': ['Drug: F/TAF', 'Drug: DTG', 'Drug: BIC Placebo', 'Drug: B/F/TAF']}, {'type': 'EXPERIMENTAL', 'label': 'Open Label Extension Phase', 'description': 'After Week 48 participants continued to take their randomized 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 participate in an open-label rollover extension to receive an FDC containing B/F/TAF.', 'interventionNames': ['Drug: B/F/TAF']}], 'interventions': [{'name': 'BIC', 'type': 'DRUG', 'otherNames': ['GS-9883'], 'description': '75 mg tablet administered orally once daily', 'armGroupLabels': ['BIC + F/TAF']}, {'name': 'F/TAF', 'type': 'DRUG', 'description': '200/25 mg FDC tablet administered orally once daily', 'armGroupLabels': ['BIC + F/TAF', 'DTG + F/TAF']}, {'name': 'DTG', 'type': 'DRUG', 'otherNames': ['Tivicay®'], 'description': '50 mg tablet administered orally once daily', 'armGroupLabels': ['DTG + F/TAF']}, {'name': 'BIC Placebo', 'type': 'DRUG', 'description': 'Tablet administered orally once daily', 'armGroupLabels': ['DTG + F/TAF']}, {'name': 'DTG Placebo', 'type': 'DRUG', 'description': 'Tablet administered orally once daily', 'armGroupLabels': ['BIC + F/TAF']}, {'name': 'B/F/TAF', 'type': 'DRUG', 'description': '50/200/25 mg FDC tablet administered orally once daily', 'armGroupLabels': ['BIC + F/TAF', 'DTG + F/TAF', 'Open Label Extension Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48072', 'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75605', 'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}