Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
Completed
- Conditions
- HIV-1-infection
- Interventions
- Drug: B/F/TAF
- Registration Number
- NCT03580668
- Lead Sponsor
- Gilead Sciences
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description B/F/TAF B/F/TAF Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in CD4 Cell Count at 3 Months 3 months Change in CD4 Cell Count at 48 Months 48 months CD4/CD8 Ratio at 3 Months 3 months 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 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 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 Change in CD4 Cell Count at 12 Months 12 months Change in CD4 Cell Count at 60 Months 60 months CD4/CD8 Ratio at 6 Months 6 months 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 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 CD4/CD8 Ratio at 24 Months 24 months CD4/CD8 Ratio at 36 Months 36 months 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 CD4/CD8 Ratio at 12 Months 12 months CD4/CD8 Ratio at 48 Months 48 months Proportion of Participants Experiencing Adverse Events (AEs) 60 months Proportion of Participants Experiencing and Serious Adverse Events (SAEs) 60 months Change in CD4 Cell Count at 24 Months 24 months Change in CD4 Cell Count at 36 Months 36 months CD4/CD8 Ratio at 60 Months 60 months Change in CD4 Cell Count at 6 Months 6 months
Trial Locations
- Locations (6)
Spectrum Health
🇨🇦Vancouver, Canada
Regina General Hospital
🇨🇦Regina, Canada
Clinique Medicale du Quartier Latin
🇨🇦Montréal, Canada
University of Ottawa
🇨🇦Ottawa, Canada
St. Clair Medical Association/Balmoral Clinic
🇨🇦Toronto, Canada
Maple Leaf Research
🇨🇦Toronto, Canada