Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT04009057
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2019-07-02
Is NOT Gene Therapy:
True
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 (B/F/TAF)
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': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage 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': 'Percentage 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': 'Percentage 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': 'Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '3 Months'}, {'measure': 'Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '6 Months'}, {'measure': 'Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '12 Months'}, {'measure': 'Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '24 Months'}, {'measure': 'CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '3 Months'}, {'measure': 'CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '6 Months'}, {'measure': 'CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '12 Months'}, {'measure': 'CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF', 'timeFrame': '24 Months'}, {'measure': 'Percentage of Participants Experiencing Adverse Events and Serious Adverse Events', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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.'}]}, '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 antiretroviral therapy (ART)-naïve and ART-experienced HIV-1 infected adults aged ≥ 18 years initiating treatment with B/F/TAF in routine clinical care in Israel.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* Signed informed consent\n* Initiating treatment with B/F/TAF\n\nExclusion Criteria:\n\n* Participation in any interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT04009057', 'acronym': 'BIC-STaR', 'briefTitle': 'Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Multi-center, Israeli, 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-IL-380-5335'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'B/F/TAF', 'description': 'HIV-1 infected adults who initiate B/F/TAF therapy', 'interventionNames': ['Other: B/F/TAF']}], 'interventions': [{'name': 'B/F/TAF', 'type': 'OTHER', 'otherNames': ['Biktarvy®'], 'description': 'B/F/TAF administered in accordance with the approved product monograph', 'armGroupLabels': ['B/F/TAF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Souraski Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}