Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02607956
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2015-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Gabon']}, 'interventionBrowseModule': {'meshes': [{'id': 'C562325', 'term': 'dolutegravir'}, {'id': 'C000613801', 'term': 'emtricitabine tenofovir alafenamide'}, {'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, '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': 'Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)', 'description': 'Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.\n\nAll-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.', 'eventGroups': [{'id': 'EG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.', 'otherNumAtRisk': 320, 'deathsNumAtRisk': 327, 'otherNumAffected': 250, 'seriousNumAtRisk': 320, 'deathsNumAffected': 4, 'seriousNumAffected': 64}, {'id': 'EG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.', 'otherNumAtRisk': 325, 'deathsNumAtRisk': 330, 'otherNumAffected': 262, 'seriousNumAtRisk': 325, 'deathsNumAffected': 4, 'seriousNumAffected': 46}, {'id': 'EG002', 'title': 'B/F/TAF to B/F/TAF', 'description': 'After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.', 'otherNumAtRisk': 254, 'deathsNumAtRisk': 254, 'otherNumAffected': 165, 'seriousNumAtRisk': 254, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 163, 'seriousNumAtRisk': 265, 'deathsNumAffected': 3, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anal chlamydia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gonorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Proctitis gonococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 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24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tonsillar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophagogastric fundoplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.002', 'paramValue': '-3.5', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '1.0', 'estimateComment': 'Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.'}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).'}], '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': 'Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '3.2', 'estimateComment': 'Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).'}], '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 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 Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000'}, {'value': '84.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '3.9', 'estimateComment': 'Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 144', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 144 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 Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000'}, {'value': '87.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '1.5', 'estimateComment': 'The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).'}], '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 status using only the viral load at the predefined time point within an allowed window of time, along with 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'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '3.8', 'estimateComment': 'The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 96 was analyzed using 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orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '79.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '5.3', 'estimateComment': 'The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \\> 100,000 copies/mL) and region stratum (US vs. Ex-US).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 144', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 144 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': 'Change From Baseline in log10 HIV-1 RNA at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.07', 'spread': '0.719', 'groupId': 'OG000'}, {'value': '-3.12', 'spread': '0.672', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.17', 'estimateComment': 'Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.'}], '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': 'Change From Baseline in log10 HIV-1 RNA at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.08', 'spread': '0.703', 'groupId': 'OG000'}, {'value': '-3.10', 'spread': '0.713', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.15', 'estimateComment': 'Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in log10 HIV-1 RNA at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.06', 'spread': '0.731', 'groupId': 'OG000'}, {'value': '-3.11', 'spread': '0.672', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.18', 'estimateComment': 'Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 144', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'spread': '166.2', 'groupId': 'OG000'}, {'value': '201', 'spread': '165.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23', 'ciLowerLimit': '-49', 'ciUpperLimit': '4', 'estimateComment': 'Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value was adjusted by the baseline HIV-1 RNA and region stratum.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full 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': '269', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '237', 'spread': '204.2', 'groupId': 'OG000'}, {'value': '281', 'spread': '209.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47', 'ciLowerLimit': '-81', 'ciUpperLimit': '-12', 'estimateComment': 'Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value was adjusted by the baseline HIV-1 RNA and region stratum.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.'}], 'classes': [{'categories': [{'measurements': [{'value': '278', 'spread': '236.6', 'groupId': 'OG000'}, {'value': '289', 'spread': '218.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14', 'ciLowerLimit': '-52', 'ciUpperLimit': '25', 'estimateComment': 'Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 144', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All B/F/TAF', 'description': 'Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'OG001', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '99.6', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, open-label Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in All B/F/TAF Analysis Set (who were randomized into the randomized phase of the study and received at least 1 dose of the B/F/TAF in the randomized phase or at least 1 dose of the B/F/TAF in the open label extension phase) with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All B/F/TAF', 'description': 'Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'OG001', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '70.2', 'upperLimit': '79.9'}, {'value': '84.5', 'groupId': 'OG001', 'lowerLimit': '79.6', 'upperLimit': '88.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, open-label Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Failure analysis, it included all participants from the Randomized Phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All B/F/TAF', 'description': 'Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'OG001', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, open-label Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All B/F/TAF', 'description': 'Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'OG001', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '62.7', 'upperLimit': '73.2'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, open-label Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Failure analysis, it included all participants from the Randomized Phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48 Open-Label', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All B/F/TAF', 'description': 'Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'OG001', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'classes': [{'categories': [{'measurements': [{'value': '304', 'spread': '249.2', 'groupId': 'OG000'}, {'value': '9', 'spread': '198.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, open-label Week 48', 'unitOfMeasure': 'cells/μL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 96 Open-Label', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All B/F/TAF', 'description': 'Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'OG001', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'classes': [{'categories': [{'measurements': [{'value': '336', 'spread': '235.1', 'groupId': 'OG000'}, {'value': '-10', 'spread': '181.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, open-label Week 96', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B/F/TAF', 'description': 'Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food.'}, {'id': 'FG001', 'title': 'DTG + F/TAF', 'description': 'DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks without regard to food.'}, {'id': 'FG002', 'title': 'B/F/TAF to B/F/TAF', 'description': 'After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'FG003', 'title': 'DTG + F/TAF to B/F/TAF', 'description': 'After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}], 'periods': [{'title': 'Double-Blinded Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '327'}, {'groupId': 'FG001', 'numSubjects': '330'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '277'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'At the End of Blinded Treatment Visit, participants were given the option to receive B/F/TAF FDC in an OL extension phase for up to 96 weeks.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'At the End of Blinded Treatment Visit, participants were given the option to receive B/F/TAF FDC in an OL extension phase for up to 96 weeks.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '66 participants from the Double-Blinded Phase did not enter the Open-Label Extension Phase.', 'groupId': 'FG002', 'numSubjects': '254'}, {'comment': '60 participants from the Double-Blinded Phase did not enter the Open-Label Extension Phase.', 'groupId': 'FG003', 'numSubjects': '265'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '225'}, {'groupId': 'FG003', 'numSubjects': '235'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': "Investigator's Discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Non Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at centers in Australia, Europe, North America, and the Dominican Republic. The first participant was screened on 11 November 2015. The last study visit occurred on 05 July 2021.', 'preAssignmentDetails': '742 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '645', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'B/F/TAF', 'description': 'Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'BG001', 'title': 'DTG + F/TAF', 'description': 'Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food\n\nOpen-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '37', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '37', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '568', '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': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '197', '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': '183', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}, {'title': 'Dominican Republic', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA', 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '0.730', 'groupId': 'BG000'}, {'value': '4.42', 'spread': '0.669', 'groupId': 'BG001'}, {'value': '4.41', 'spread': '0.700', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV-1 RNA Categories', 'classes': [{'categories': [{'title': '≤ 100,000 copies/mL', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '525', 'groupId': 'BG002'}]}, {'title': '> 100,000 ≤ 400,000 copies/mL', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': '> 400,000 copies/mL', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '457', 'spread': '255.3', 'groupId': 'BG000'}, {'value': '454', 'spread': '231.5', 'groupId': 'BG001'}, {'value': '456', 'spread': '243.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Cell Count Categories', 'classes': [{'categories': [{'title': '< 50 cells/μL', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '≥ 50 to < 200 cells/μL', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '≥ 200 to < 350 cells/μL', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': '≥ 350 to < 500 cells/μL', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': '≥ 500 cells/μL', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-21', 'size': 2480976, 'label': 'Study Protocol: Original', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-01T14:36', 'hasProtocol': True}, {'date': '2016-02-19', 'size': 2498530, 'label': 'Study Protocol: Amendment 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_005.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-01T14:38', 'hasProtocol': True}, {'date': '2016-10-19', 'size': 2526869, 'label': 'Study Protocol: Amendment 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-01T14:39', 'hasProtocol': True}, {'date': '2019-05-06', 'size': 1349924, 'label': 'Study Protocol: Amendment 3', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_008.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-02T14:44', 'hasProtocol': True}, {'date': '2017-05-10', 'size': 1273249, 'label': 'Statistical Analysis Plan: Original', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-01T14:40', 'hasProtocol': False}, {'date': '2019-05-13', 'size': 1112222, 'label': 'Statistical Analysis Plan: Amendment 1', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_009.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-06T04:29', 'hasProtocol': False}, {'date': '2021-09-22', 'size': 1407138, 'label': 'Statistical Analysis Plan: Final Analysis', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_010.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-17T04:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2015-11-10', 'resultsFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2015-11-16', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-03', 'studyFirstPostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm', '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."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm', '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 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 Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm', 'timeFrame': 'Week 144', 'description': "The percentage of participants achieving HIV-1 RNA \\< 50 copies/mL at Week 144 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 Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm', '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 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 Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm', '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 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 Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm', 'timeFrame': 'Week 144', 'description': "The percentage of participants achieving HIV-1 RNA \\< 20 copies/mL at Week 144 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': 'Change From Baseline in log10 HIV-1 RNA at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in log10 HIV-1 RNA at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Change From Baseline in log10 HIV-1 RNA at Week 144', 'timeFrame': 'Baseline, Week 144'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 144', 'timeFrame': 'Baseline, Week 144'}, {'measure': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm', 'timeFrame': 'Baseline, open-label Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.'}, {'measure': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm', 'timeFrame': 'Baseline, open-label Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.'}, {'measure': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm', 'timeFrame': 'Baseline, open-label Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.'}, {'measure': 'Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm', 'timeFrame': 'Baseline, open-label Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 48 Open-Label', 'timeFrame': 'Baseline, open-label Week 48'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 96 Open-Label', 'timeFrame': 'Baseline, open-label Week 96'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '28867499', 'type': 'RESULT', 'citation': 'Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31.'}, {'pmid': '30932951', 'type': 'RESULT', 'citation': 'Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.'}, {'pmid': '31068272', 'type': 'RESULT', 'citation': 'Stellbrink HJ, Arribas JR, Stephens JL, Albrecht H, Sax PE, Maggiolo F, Creticos C, Martorell CT, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e364-e372. doi: 10.1016/S2352-3018(19)30080-3. Epub 2019 May 5.'}, {'pmid': '30803969', 'type': 'RESULT', 'citation': 'Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.'}, {'type': 'RESULT', 'citation': 'Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.'}, {'type': 'RESULT', 'citation': 'Johnson M, Taylor S, Wei X, Collins SE, Martin H. Hepatic Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide [Poster P061]. 25th Annual Conference of the British HIV Association; 2019 02-05 April; Bournemouth, United Kingdom.'}, {'type': 'RESULT', 'citation': 'Gupta S, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. 96 Week Efficacy and Safety of B/F/TAF in Treatment-Naïve Adults and Adults ≥50 Years [Poster 502]. CROI 2019; 2019 04-07 March; Seattle, WA.'}, {'type': 'RESULT', 'citation': 'Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.'}, {'type': 'RESULT', 'citation': 'White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.'}, {'pmid': '29956087', 'type': 'RESULT', 'citation': 'Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.'}, {'pmid': '31068270', 'type': 'RESULT', 'citation': 'Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.'}, {'type': 'RESULT', 'citation': "Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts."}, {'type': 'RESULT', 'citation': 'Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.'}, {'pmid': '32504574', 'type': 'RESULT', 'citation': 'Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.'}, {'type': 'RESULT', 'citation': 'Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtrictabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.'}, {'type': 'RESULT', 'citation': "Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom."}, {'type': 'RESULT', 'citation': 'Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.'}, {'pmid': '33880558', 'type': 'RESULT', 'citation': 'Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.'}, {'type': 'RESULT', 'citation': 'Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.'}, {'type': 'RESULT', 'citation': 'Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naive Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.'}, {'type': 'RESULT', 'citation': 'Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.'}, {'type': 'RESULT', 'citation': 'Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.'}, {'type': 'RESULT', 'citation': 'Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29- October 3; Virtual.'}, {'type': 'RESULT', 'citation': 'Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG+F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.'}, {'pmid': '39229805', 'type': 'DERIVED', 'citation': 'Sax PE, Hindman JT, Martin H, Wohl D. Two 5-year studies of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: a plain-language summary. Future Microbiol. 2024;19(14):1185-1193. doi: 10.1080/17460913.2024.2372231. Epub 2024 Sep 4.'}, {'pmid': '38349226', 'type': 'DERIVED', 'citation': 'Orkin C, Antinori A, Rockstroh JK, Moreno-Guillen S, Martorell CT, Molina JM, Lazzarin A, Maggiolo F, Yazdanpanah Y, Andreatta K, Huang H, Hindman JT, Martin H, Pozniak A. Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy. AIDS. 2024 Jun 1;38(7):983-991. doi: 10.1097/QAD.0000000000003865. Epub 2024 Feb 21.'}, {'pmid': '37200995', 'type': 'DERIVED', 'citation': 'Sax PE, Arribas JR, Orkin C, Lazzarin A, Pozniak A, DeJesus E, Maggiolo F, Stellbrink HJ, Yazdanpanah Y, Acosta R, Huang H, Hindman JT, Martin H, Baeten JM, Wohl D; GS-US-380-1489 and GS-US-380-1490 study investigators. Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. EClinicalMedicine. 2023 May 11;59:101991. doi: 10.1016/j.eclinm.2023.101991. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening\n* Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening\n* Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula\n\nKey Exclusion Criteria:\n\n* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening\n* Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)\n* Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance\n* Females who are pregnant (as confirmed by positive serum pregnancy test)\n* Females who are breastfeeding\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02607956', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind Study to Evaluate 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-380-1490'}, 'secondaryIdInfos': [{'id': '2015-003988-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B/F/TAF', 'description': 'B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.', 'interventionNames': ['Drug: B/F/TAF', 'Drug: DTG Placebo', 'Drug: F/TAF Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DTG + F/TAF', 'description': 'DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.', 'interventionNames': ['Drug: DTG', 'Drug: F/TAF', 'Drug: B/F/TAF Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Open-label Phase B/F/TAF from B/F/TAF', 'description': 'After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.', 'interventionNames': ['Drug: B/F/TAF']}, {'type': 'EXPERIMENTAL', 'label': 'Open-label Phase B/F/TAF from DTG + F/TAF', 'description': 'After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.', 'interventionNames': ['Drug: B/F/TAF']}], 'interventions': [{'name': 'DTG', 'type': 'DRUG', 'otherNames': ['Tivicay®'], 'description': '50 mg tablets administered orally, once daily', 'armGroupLabels': ['DTG + F/TAF']}, {'name': 'F/TAF', 'type': 'DRUG', 'otherNames': ['Descovy®'], 'description': '200/25 mg tablets administered orally, once daily', 'armGroupLabels': ['DTG + F/TAF']}, {'name': 'B/F/TAF', 'type': 'DRUG', 'otherNames': ['GS-9883/F/TAF', 'Biktarvy®'], 'description': '50/200/25 milligrams (mg) FDC tablets administered orally, once daily', 'armGroupLabels': ['B/F/TAF', 'Open-label Phase B/F/TAF from B/F/TAF', 'Open-label Phase B/F/TAF from DTG + F/TAF']}, {'name': 'DTG Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally, once daily', 'armGroupLabels': ['B/F/TAF']}, {'name': 'F/TAF Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally, once daily', 'armGroupLabels': ['B/F/TAF']}, {'name': 'B/F/TAF Placebo', 'type': 'DRUG', 'description': 'Tablets administered orally, once daily', 'armGroupLabels': ['DTG + F/TAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85025', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90059', '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': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94102', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Optimus Medical - ClinEdge - PPDS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '80205', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'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': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34982', 'city': 'Ft. 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