Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT03580668
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2018-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2018-06-26', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF', 'timeFrame': '3 months'}, {'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months after initiating or switching to B/F/TAF', 'timeFrame': '6 months'}, {'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months after initiating or switching to B/F/TAF', 'timeFrame': '24 months'}, {'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF', 'timeFrame': '36 months'}, {'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF', 'timeFrame': '48 months'}, {'measure': 'Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF', 'timeFrame': '60 months'}, {'measure': 'Change in CD4 Cell Count at 3 Months', 'timeFrame': '3 months'}, {'measure': 'Change in CD4 Cell Count at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Change in CD4 Cell Count at 12 Months', 'timeFrame': '12 months'}, {'measure': 'Change in CD4 Cell Count at 24 Months', 'timeFrame': '24 months'}, {'measure': 'Change in CD4 Cell Count at 36 Months', 'timeFrame': '36 months'}, {'measure': 'Change in CD4 Cell Count at 48 Months', 'timeFrame': '48 months'}, {'measure': 'Change in CD4 Cell Count at 60 Months', 'timeFrame': '60 months'}, {'measure': 'CD4/CD8 Ratio at 3 Months', 'timeFrame': '3 months'}, {'measure': 'CD4/CD8 Ratio at 6 Months', 'timeFrame': '6 months'}, {'measure': 'CD4/CD8 Ratio at 12 Months', 'timeFrame': '12 months'}, {'measure': 'CD4/CD8 Ratio at 24 Months', 'timeFrame': '24 months'}, {'measure': 'CD4/CD8 Ratio at 36 Months', 'timeFrame': '36 months'}, {'measure': 'CD4/CD8 Ratio at 48 Months', 'timeFrame': '48 months'}, {'measure': 'CD4/CD8 Ratio at 60 Months', 'timeFrame': '60 months'}, {'measure': 'Proportion of Participants Experiencing Adverse Events (AEs)', 'timeFrame': '60 months'}, {'measure': 'Proportion of Participants Experiencing and Serious Adverse Events (SAEs)', 'timeFrame': '60 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Observational'], 'conditions': ['HIV-1-infection']}, 'referencesModule': {'references': [{'pmid': '41284214', 'type': 'DERIVED', 'citation': 'Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2025 Nov 24. doi: 10.1007/s40121-025-01252-w. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=GS-CA-380-4574', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA \\<50 copies/mL, at 12 months after initiating or switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be comprised of ART-naïve and ART-experienced HIV-1 infected adults aged ≥18 years initiating treatment with B/F/TAF in routine clinical care in Canada.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* Signed informed consent\n* Initiating treatment with B/F/TAF in accordance with the product monograph\n\nExclusion Criteria:\n\nParticipation in any other observational or interventional clinical trial without prior approval from the Medical Monitor'}, 'identificationModule': {'nctId': 'NCT03580668', 'acronym': 'BIC-STaR', 'briefTitle': 'Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Multi-center, Canadian, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)', 'orgStudyIdInfo': {'id': 'GS-CA-380-4574'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'B/F/TAF', 'description': 'Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy', 'interventionNames': ['Drug: B/F/TAF']}], 'interventions': [{'name': 'B/F/TAF', 'type': 'DRUG', 'otherNames': ['Biktarvy®'], 'description': 'B/F/TAF administered in accordance with the approved product monograph', 'armGroupLabels': ['B/F/TAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L 4E9', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Clinique Medicale du Quartier Latin', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'K1N 6N5', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'S4P 0W5', 'city': 'Regina', 'country': 'Canada', 'facility': 'Regina General Hospital', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': 'M4T3A7', 'city': 'Toronto', 'country': 'Canada', 'facility': 'St. Clair Medical Association/Balmoral Clinic', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1K2', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Maple Leaf Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'V6Z 2T1', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}