Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT03405935
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years
Sponsor:
Organization:
Raw JSON
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'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events: First dose of study drug up to last dose plus 30 days (up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9', 'description': 'The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 34, 'seriousNumAtRisk': 86, 'deathsNumAffected': 2, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The percentage of participants with 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 timepoint within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all participants who were enrolled and received at least 1 dose of study drug; and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date up to Week 24', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing AEs Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date Up to Week 48', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing AEs Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date Up to Week 72', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing AEs Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose date Up to Week 96', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The percentage of participants with 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 timepoint within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': "The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 72 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': "The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'spread': '141.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', '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 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '174.8', 'groupId': 'OG000'}]}]}], '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 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '145.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', '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': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '150.9', 'groupId': 'OG000'}]}]}], '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 Percentage at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '3.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'percentage of lymphocytes', '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 Percentage at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '3.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'unitOfMeasure': 'percentage of lymphocytes', '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 Percentage at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 72', 'unitOfMeasure': 'percentage of lymphocytes', '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 Percentage at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '4.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 72 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using missing = failure approach. 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The first participant was screened on 01 March 2018. The last study visit occurred on 29 May 2020.', 'preAssignmentDetails': '90 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'B/F/TAF', 'description': 'B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted = Data not collected due to regional regulations or participant refused to provide information', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'Not Permitted', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Not Permitted = Data not collected due to regional regulations or participant refused to provide information', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Human Immunodeficiency Virus-1 Ribonucleic acid (HIV-1 RNA) Category', 'classes': [{'categories': [{'title': '< 50 copies/mL', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': '≥ 50 copies/mL', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Cluster of Differentiation 4 (CD4) Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '694', 'spread': '273.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CD4 Cell Count Category', 'classes': [{'categories': [{'title': '< 50 cells/µL', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '≥ 50 to < 200 cells/µL', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '≥ 200 to < 350 cells/µL', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '≥ 350 to < 500 cells/µL', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '≥ 500 cells/µL', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'CD4 Percentage', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '9.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of lymphocytes', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-18', 'size': 2505791, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-04T14:41', 'hasProtocol': True}, {'date': '2020-08-19', 'size': 727440, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-07T03:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2018-01-12', 'resultsFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-18', 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm', 'timeFrame': 'Week 24', 'description': "The percentage of participants with 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 timepoint within an allowed window of time, along with study drug discontinuation status."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24', 'timeFrame': 'First dose date up to Week 24', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.'}, {'measure': 'Percentage of Participants Experiencing AEs Through Week 48', 'timeFrame': 'First dose date Up to Week 48', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.'}, {'measure': 'Percentage of Participants Experiencing AEs Through Week 72', 'timeFrame': 'First dose date Up to Week 72', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.'}, {'measure': 'Percentage of Participants Experiencing AEs Through Week 96', 'timeFrame': 'First dose date Up to Week 96', 'description': 'An 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. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm', 'timeFrame': 'Week 48', 'description': "The percentage of participants with 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 timepoint within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm', 'timeFrame': 'Week 72', 'description': "The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 72 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm', 'timeFrame': 'Week 96', 'description': "The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status."}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 72', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Change From Baseline in CD4 Percentage at Week 24', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Change From Baseline in CD4 Percentage at Week 48', 'timeFrame': 'Baseline, Week 48'}, {'measure': 'Change From Baseline in CD4 Percentage at Week 72', 'timeFrame': 'Baseline, Week 72'}, {'measure': 'Change From Baseline in CD4 Percentage at Week 96', 'timeFrame': 'Baseline, Week 96'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach', 'timeFrame': 'Week 24', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach', 'timeFrame': 'Week 72', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 72 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach', 'timeFrame': 'Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach', 'timeFrame': 'Week 24', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 24 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach', 'timeFrame': 'Week 48', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 48 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach', 'timeFrame': 'Week 72', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 72 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach', 'timeFrame': 'Week 96', 'description': 'The percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 96 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '35527425', 'type': 'DERIVED', 'citation': "Maggiolo F, Rizzardini G, Molina JM, Pulido F, De Wit S, Vandekerckhove L, Berenguer J, D'Antoni ML, Blair C, Chuck SK, Piontkowsky D, Martin H, Haubrich R, McNicholl IR, Gallant J. Bictegravir/emtricitabine/tenofovir alafenamide in older individuals with HIV: Results of a 96-week, phase 3b, open-label, switch trial in virologically suppressed people >/=65 years of age. HIV Med. 2023 Jan;24(1):27-36. doi: 10.1111/hiv.13319. Epub 2022 May 8."}, {'pmid': '33686573', 'type': 'DERIVED', 'citation': "Maggiolo F, Rizzardini G, Molina JM, Pulido F, De Wit S, Vandekerckhove L, Berenguer J, D'Antoni ML, Blair C, Chuck SK, Piontkowsky D, Martin H, Haubrich R, McNicholl IR, Gallant J. Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged >/= 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Infect Dis Ther. 2021 Jun;10(2):775-788. doi: 10.1007/s40121-021-00419-5. Epub 2021 Mar 9."}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine \\[FTC\\]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \\[NCT02616783\\]) for ≥ 3 months\n* Documented plasma HIV-1 ribonucleic acid (RNA) \\< 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \\[NCT02616783\\]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)\n* Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance\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 participant study compliance\n\nNote: Other protocol defined Inclusion/ Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03405935', 'briefTitle': 'Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years', 'orgStudyIdInfo': {'id': 'GS-US-380-4449'}, 'secondaryIdInfos': [{'id': '2017-003428-61', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B/F/TAF', 'description': 'B/F/TAF FDC for at least 96 weeks.', 'interventionNames': ['Drug: B/F/TAF']}], 'interventions': [{'name': 'B/F/TAF', 'type': 'DRUG', 'otherNames': ['Biktarvy®'], 'description': '50/200/25 mg FDC tablet administered orally once daily without regard to food.', 'armGroupLabels': ['B/F/TAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Saint-Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '13006', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Europeen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'C.H.U. de Nantes - Hotel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '6203', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Necker - Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33064', 'city': 'Pessac', 'country': 'France', 'facility': 'Interne et Maladies infectieuses', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '59208', 'city': 'Tourcoing', 'country': 'France', 'facility': 'CH de Tourcoing', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'ASST Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST - Fatebenefratelli Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '65124', 'city': 'Pescara', 'country': 'Italy', 'facility': 'P.O. Spirito Santo - U.O. Malattie Infettive e Tropicali', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '00149', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '8916', 'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08026', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29603', 'city': 'Marbella', 'country': 'Spain', 'facility': 'Hospital Costa Del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '18 months after study completion', 'ipdSharing': 'YES', 'description': 'Qualified external researchers may request IPD for this study after study completion. 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'}}}}