BIC-STaR: Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| B/F/TAF Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy |
Drug: B/F/TAF
B/F/TAF administered in accordance with the approved product monograph
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 24 Months after initiating or switching to B/F/TAF [24 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 48 Months after initiating or switching to B/F/TAF [48 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 3 Months [3 months]
- Change in CD4 Cell Count at 6 Months [6 months]
- Change in CD4 Cell Count at 12 Months [12 months]
- Change in CD4 Cell Count at 24 Months [24 months]
- Change in CD4 Cell Count at 36 Months [36 months]
- Change in CD4 Cell Count at 48 Months [48 months]
- Change in CD4 Cell Count at 60 Months [60 months]
- CD4/CD8 Ratio at 3 Months [3 months]
- CD4/CD8 Ratio at 6 Months [6 months]
- CD4/CD8 Ratio at 12 Months [12 months]
- CD4/CD8 Ratio at 24 Months [24 months]
- CD4/CD8 Ratio at 36 Months [36 months]
- CD4/CD8 Ratio at 48 Months [48 months]
- CD4/CD8 Ratio at 60 Months [60 months]
- Proportion of Participants Experiencing Adverse Events (AEs) [60 months]
- Proportion of Participants Experiencing and Serious Adverse Events (SAEs) [60 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Medicale du Quartier Latin | Montréal | Canada | H2L 4E9 | |
| 2 | University of Ottawa | Ottawa | Canada | K1N 6N5 | |
| 3 | Regina General Hospital | Regina | Canada | S4P 0W5 | |
| 4 | St. Clair Medical Association/Balmoral Clinic | Toronto | Canada | M4T3A7 | |
| 5 | Maple Leaf Research | Toronto | Canada | M5G 1K2 | |
| 6 | Spectrum Health | Vancouver | Canada | V6Z 2T1 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-CA-380-4574