HIV-1-infection
Conditions
Keywords
Observational
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).
Interventions
DRUGB/F/TAF
B/F/TAF administered in accordance with the approved product monograph
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Change in CD4 Cell Count at 48 Months | 48 months |
Countries
Canada
Outcome results
None listed