Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT03631732
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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 B/F/TAF dose date up to Week 72 plus 30 days. All-Cause Mortality: Randomization up to Week 72 plus 30 days.', 'description': 'The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1).\n\nAll-Cause Mortality: The All Randomized Analysis Set included all participants who were randomized into the study.', 'eventGroups': [{'id': 'EG000', 'title': 'B/F/TAF up to Week 24', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 24 weeks, without regard to food.', 'otherNumAtRisk': 330, 'deathsNumAtRisk': 331, 'otherNumAffected': 38, 'seriousNumAtRisk': 330, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'SBR up to Week 24', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 13, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'B/F/TAF After Week 24', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily from Week 24 to Week 48, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.', 'otherNumAtRisk': 319, 'deathsNumAtRisk': 319, 'otherNumAffected': 53, 'seriousNumAtRisk': 319, 'deathsNumAffected': 2, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Delayed B/F/TAF', 'description': 'Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 26, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Burn infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neurosyphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperglycaemic hyperosmolar nonketotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertebral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 319, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 163, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'Stay on Baseline Regimen (SBR)', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.2'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '5.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '0.9', 'estimateComment': 'Differences in percentages of participants with HIV-1 RNA \\>= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (CI) of the difference between treatment groups \\[B/F/TAF - SBR\\] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).'}, {'pValue': '0.3399', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set \\[included all participants who were randomized into the study, and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and did not have pre-existing integrase strand transfer inhibitor resistance-associated mutations (based on historical data)\\] in B/F/TAF and SBR groups were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'OG001', 'title': 'Delayed B/F/TAF', 'description': 'Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.6'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'Stay on Baseline Regimen (SBR)', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.1'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '89.9', 'upperLimit': '97.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '6.8', 'estimateComment': 'Differences in percentages of participants with HIV-1 RNA \\< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \\[B/F/TAF - SBR\\] in the percentage of participants with HIV-1 RNA \\< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).'}, {'pValue': '0.3532', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The percentage of participants who had HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set in the B/F/TAF and SBR groups were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'Stay on Baseline Regimen (SBR)', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '99.9'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '99.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '5.3', 'estimateComment': 'Differences in percentages of participants with HIV-1 RNA \\< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \\[B/F/TAF - SBR\\] in the percentage of participants with HIV-1 RNA \\< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).'}, {'pValue': '0.3356', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The percentage of participants who had HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 24 Per Protocol Analysis Set \\[included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1), and had not committed any major protocol violation, including the violation of key entry criteria\\] in the B/F/TAF and SBR groups were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'OG001', 'title': 'Delayed B/F/TAF', 'description': 'Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '96.7'}, {'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '93.0', 'upperLimit': '99.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants who had HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'Stay on Baseline Regimen (SBR)', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '209.3', 'groupId': 'OG000'}, {'value': '1', 'spread': '171.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5618', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11', 'ciLowerLimit': '-27', 'ciUpperLimit': '49', 'estimateComment': 'Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value was calculated from ANOVA model with treatment as a fixed effect.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The analysis includes values up to 1 day after permanent discontinuation of study treatment.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food.'}, {'id': 'OG001', 'title': 'Stay on Baseline Regimen (SBR)', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '210.1', 'groupId': 'OG000'}, {'value': '4', 'spread': '171.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6632', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LSM', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9', 'ciLowerLimit': '-31', 'ciUpperLimit': '48', 'estimateComment': 'Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value was calculated from ANOVA model with treatment as a fixed effect.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The analysis includes values up to 1 day after permanent discontinuation of study treatment.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Week 24 Per Protocol Analysis Set in the B/F/TAF and SBR groups with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'OG001', 'title': 'Delayed B/F/TAF', 'description': 'Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '188.6', 'groupId': 'OG000'}, {'value': '-8', 'spread': '159.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set in the B/F/TAF and the Delayed B/F/TAF groups with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'OG001', 'title': 'Delayed B/F/TAF', 'description': 'Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '69.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First B/F/TAF dose date up to Week 72 plus 30 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The B/F/TAF (BVY) Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of BVY study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'OG001', 'title': 'Delayed B/F/TAF', 'description': 'Participants in SBR group who switched to B/F/TAF group at Week 24 received B/F/TAF (50/200/25 mg) FDC tablet orally, once daily from Week 24 until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}, {'value': '80.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First B/F/TAF dose date up to Week 72 plus 30 days', 'description': "Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the BVY Safety Analysis Set with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B/F/TAF', 'description': 'Participants received bictegravir /emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed dose combination (FDC) tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'FG001', 'title': 'Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF', 'description': 'Participants stayed on baseline regimen consisting of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}], 'periods': [{'title': 'Randomized Phase Up to Week 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '331'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'B/F/TAF Treatment Phase (After Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '5 participants completed 24 weeks of the study, but did not receive study treatment after Week 24.', 'groupId': 'FG000', 'numSubjects': '319'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '303'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': "Investigator's discretion", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study centers in the United States. The first participant was screened on 28 August 2018. The last study visit occurred on 19 August 2020.', 'preAssignmentDetails': 'The following NRTIs \\& 3rd agents were allowed:\n\nNRTIs:abacavir, emtricitabine, lamivudine, tenofovir alafenamide, tenofovir disoproxil fumarate, zidovudine;\n\n3rd agents:delavirdine,efavirenz, nevirapine, rilpivirine,dolutegravir, elvitegravir,raltegravir, doravirine, atazanavir, darunavir, lopinavir, nelfinavir, saquinavir, tipranavir, maraviroc'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '495', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'B/F/TAF', 'description': 'Participants received B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'BG001', 'title': 'Stay on Baseline Regimen/ Delayed B/F/TAF', 'description': 'Participants stayed on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wished to continue on B/F/TAF were given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they had access to B/F/TAF, whichever occurred first.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '48', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '47', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HIV-1 RNA Category', 'classes': [{'categories': [{'title': '< 50 copies/mL', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '488', 'groupId': 'BG002'}]}, {'title': '≥ 50 copies/mL', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'CD4+ Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '765', 'spread': '313.4', 'groupId': 'BG000'}, {'value': '757', 'spread': '323.0', 'groupId': 'BG001'}, {'value': '763', 'spread': '316.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study treatment (either B/F/TAF or baseline regimen on Day 1).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-27', 'size': 2218757, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-14T17:02', 'hasProtocol': True}, {'date': '2019-08-30', 'size': 2239268, 'label': 'Statistical Analysis Plan: Week 24 Analysis', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-14T17:04', 'hasProtocol': False}, {'date': '2020-11-16', 'size': 2052377, 'label': 'Statistical Analysis Plan: Final Analysis', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-10T07:45', 'hasProtocol': False}, {'date': '2020-03-03', 'size': 2122545, 'label': 'Statistical Analysis Plan: Week 48 Analysis', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-05T14:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 496}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2018-08-13', 'resultsFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-12', 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'timeFrame': 'Week 24', 'description': "The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'timeFrame': 'Week 48', 'description': "The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF."}, {'measure': 'Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'timeFrame': 'Week 24', 'description': "The percentage of participants who had HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set', 'timeFrame': 'Week 24', 'description': "The percentage of participants who had HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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 Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set', 'timeFrame': 'Week 48', 'description': "The percentage of participants who had HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF."}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set', 'timeFrame': 'Baseline to Week 24', 'description': 'The analysis includes values up to 1 day after permanent discontinuation of study treatment.'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set', 'timeFrame': 'Baseline to Week 24', 'description': 'The analysis includes values up to 1 day after permanent discontinuation of study treatment.'}, {'measure': 'Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set', 'timeFrame': 'Baseline to Week 48', 'description': 'The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Adverse Events', 'timeFrame': 'First B/F/TAF dose date up to Week 72 plus 30 days', 'description': 'An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation.'}, {'measure': 'Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities', 'timeFrame': 'First B/F/TAF dose date up to Week 72 plus 30 days', 'description': "Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': "Andreatta K, D'Antoni ML, Chang S, Parvangada A, Martin R, Blair C, et al. Preexisting Resistance and Week 48 Virologic Outcomes after Switching to B/F/TAF in African American Adults With HIV [Presentation]. IDWeek Virtual; 2020b 21-25 October."}, {'type': 'RESULT', 'citation': 'Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Week-48 Outcomes From the BRAAVE 2020 Study: a Randomized Switch to B/F/TAF in African-American Adults With HIV, IDWeek 2020, October 21-25. Abstract 1046.'}, {'type': 'RESULT', 'citation': "Andreatta K, D'Antoni ML, Chang S, Martin R, Blair C, Collins SE, et al. Preexisting Resistance and B/F/TAF Switch Efficacy in African Americans [Poster 509]. Conference on Retroviruses and Opportunistic Infections (CROI); 2020b 08-11 March; Boston, MA."}, {'type': 'RESULT', 'citation': 'Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopol M, McDonald C, Blair C, Andreatta K, Collins SE, Brainard D, Martin H. Randomized Switch to B/F/TAF in African American Adults with HIV. Conference on Retroviruses and Opportunistic Infections 2020, March 7-11, Boston MA. Abstract 2979.'}, {'pmid': '34397746', 'type': 'RESULT', 'citation': 'Hagins D, Kumar P, Saag M, Wurapa AK, Brar I, Berger D, Osiyemi O, Hileman CO, Ramgopal MN, McDonald C, Blair C, Andreatta K, Collins SE, Brainard DM, Martin H; BRAAVE2020 Investigators. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study. J Acquir Immune Defic Syndr. 2021 Sep 1;88(1):86-95. doi: 10.1097/QAI.0000000000002731.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Self-describes as Black, African American, or mixed race, including Black\n* Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months\n* Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc\n* If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded\n* Baseline regimens containing investigational drugs or \\> 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI)\n* Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving \\<50 copies/mL while on an INSTI-containing regimen)\n* History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded\n* Documented plasma HIV-1 RNA \\< 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit\n* HIV-1 RNA levels \\< 50 copies/mL at Screening\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance\n\nKey Exclusion Criteria:\n\n* History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT\n* No desire to switch from current ARVs\n* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening\n* Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding)\n* Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)\n* Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed\n* Current alcohol or substance use judged by the Investigator to potentially interfere with participant study compliance\n* Active, serious infections (other than HIV-1 infection) requiring antibiotic or antifungal therapy within 30 days prior to Day 1\n* Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial\n* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements\n* Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation excipient\n* Females who are pregnant (as confirmed by positive serum pregnancy test)\n* Females who are breastfeeding\n* Acute hepatitis in the 30 days prior to randomization\n* Active tuberculosis infection.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT03631732', 'acronym': 'BRAAVE 2020', 'briefTitle': 'Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants', 'orgStudyIdInfo': {'id': 'GS-US-380-4580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B/F/TAF', 'description': 'Participants will receive B/F/TAF (50/200/25 mg) FDC tablet orally once daily for 48 weeks, without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.', 'interventionNames': ['Drug: B/F/TAF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF', 'description': 'Participants will stay on baseline regimen consisting of 2 NRTIs and a third agent (each taken as prescribed) for 24 weeks with a delayed switch to B/F/TAF (50/200/25 mg) FDC tablet administered orally, once daily until Week 48 without regard to food. At Week 48, participants who wish to continue on B/F/TAF will be given the option to receive B/F/TAF FDC for up to an additional 24 weeks or until they have access to B/F/TAF, whichever occurs first.', 'interventionNames': ['Drug: B/F/TAF', 'Drug: NRTIs', 'Drug: Third Agent']}], 'interventions': [{'name': 'B/F/TAF', 'type': 'DRUG', 'otherNames': ['Biktarvy®'], 'description': '50/200/25 mg FDC tablets administered orally once daily without regard to food', 'armGroupLabels': ['B/F/TAF', 'Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF']}, {'name': 'NRTIs', 'type': 'DRUG', 'description': 'The following NRTIs will be administered as prescribed until Week 24 without regard to food:\n\nabacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT)', 'armGroupLabels': ['Stay on Baseline Regimen (SBR)/ Delayed B/F/TAF']}, {'name': 'Third Agent', 'type': 'DRUG', 'description': 'Any one of the following third agents will be administered as prescribed. 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Martorell, MD, LLC d/b/a The Research Institute', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '48072', 'city': 'Berkley', 'state': 'Michigan', 'country': 'United States', 'facility': 'Be Well Medical Center', 'geoPoint': {'lat': 42.50309, 'lon': -83.18354}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University- Integrative Bioscience Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. John Newland Medical Associates', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center, Positive Care Clinic', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': "G.V. 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For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}