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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/TAF) therapy in HIV-1 infected adults who initiate B/F/TAF therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | B/F/TAF administered in accordance with the approved product monograph |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor
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The study population will be comprised of ART-naïve and ART-experienced HIV-1 infected adults aged ≥18 years initiating treatment with B/F/TAF in routine clinical care in Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Medicale du Quartier Latin | Montreal | H2L 4E9 | Canada | |||
| University of Ottawa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41284214 | Derived | Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2026 Jan;15(1):217-244. doi: 10.1007/s40121-025-01252-w. Epub 2025 Nov 24. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| 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 |
| Ottawa |
| K1N 6N5 |
| Canada |
| Regina General Hospital | Regina | S4P 0W5 | Canada |
| St. Clair Medical Association/Balmoral Clinic | Toronto | M4T3A7 | Canada |
| Maple Leaf Research | Toronto | M5G 1K2 | Canada |
| Spectrum Health | Vancouver | V6Z 2T1 | Canada |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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