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NCT03580668 Clinical Trial

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

HIV-1-infection Clinical Trial

— BIC-STaR  

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03580668
Other study ID # GS-CA-380-4574
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 13, 2018
Est. completion date June 3, 2024

Study information
Verified date June 2024
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 201
Est. completion date June 3, 2024
Est. primary completion date June 3, 2024
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 in accordance with the product monograph Exclusion Criteria: Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Clinique Medicale du Quartier Latin Montréal
Canada University of Ottawa Ottawa
Canada Regina General Hospital Regina
Canada Maple Leaf Research Toronto
Canada St. Clair Medical Association/Balmoral Clinic Toronto
Canada Spectrum Health Vancouver

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion 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 Proportion 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 Proportion 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 Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF 36 months
Secondary Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF 48 months
Secondary Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF 60 months
Secondary Change in CD4 Cell Count at 3 Months 3 months
Secondary Change in CD4 Cell Count at 6 Months 6 months
Secondary Change in CD4 Cell Count at 12 Months 12 months
Secondary Change in CD4 Cell Count at 24 Months 24 months
Secondary Change in CD4 Cell Count at 36 Months 36 months
Secondary Change in CD4 Cell Count at 48 Months 48 months
Secondary Change in CD4 Cell Count at 60 Months 60 months
Secondary CD4/CD8 Ratio at 3 Months 3 months
Secondary CD4/CD8 Ratio at 6 Months 6 months
Secondary CD4/CD8 Ratio at 12 Months 12 months
Secondary CD4/CD8 Ratio at 24 Months 24 months
Secondary CD4/CD8 Ratio at 36 Months 36 months
Secondary CD4/CD8 Ratio at 48 Months 48 months
Secondary CD4/CD8 Ratio at 60 Months 60 months
Secondary Proportion of Participants Experiencing Adverse Events (AEs) 60 months
Secondary Proportion of Participants Experiencing and Serious Adverse Events (SAEs) 60 months
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