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NCT04009057 Clinical Trial

Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

HIV-1-infection Clinical Trial

— BIC-STaR  

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04009057
Other study ID # GS-IL-380-5335
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 9, 2019
Est. completion date March 21, 2022

Study information
Verified date April 2022
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date March 21, 2022
Est. primary completion date March 21, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - HIV-1 infection - Signed informed consent - Initiating treatment with B/F/TAF Exclusion Criteria: - Participation in any interventional clinical trial

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• B/F/TAF
B/F/TAF administered in accordance with the approved product monograph

Locations
Country Name City State
Israel Rambam Medical Center Haifa
Israel Hadassah Medical Center Jerusalem
Israel Kaplan Medical Center Rehovot
Israel Tel Aviv Souraski Medical Center Tel Aviv
Israel Sheba Medical Center Tel Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after Initiating or Switching to B/F/TAF 12 Months
Secondary Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months After Initiating or Switching to B/F/TAF 3 Months
Secondary Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months After Initiating or Switching to B/F/TAF 6 Months
Secondary Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months After Initiating or Switching to B/F/TAF 24 Months
Secondary Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF 3 Months
Secondary Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF 6 Months
Secondary Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF 12 Months
Secondary Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF 24 Months
Secondary CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF 3 Months
Secondary CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF 6 Months
Secondary CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF 12 Months
Secondary CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF 24 Months
Secondary Percentage of Participants Experiencing Adverse Events and Serious Adverse Events 24 Months
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