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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 | HIV-1 infected adults who initiate B/F/TAF therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Other | B/F/TAF administered in accordance with the approved product monograph |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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 |
|---|---|---|
| Percentage 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:
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The study population will be comprised of antiretroviral therapy (ART)-naïve and ART-experienced HIV-1 infected adults aged ≥ 18 years initiating treatment with B/F/TAF in routine clinical care in Israel.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | 3109601 | Israel | |||
| Hadassah Medical Center |
| 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. |
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| 6 Months |
| Percentage 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 |
| Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF | 3 Months |
| Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF | 6 Months |
| Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF | 12 Months |
| Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF | 24 Months |
| CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF | 3 Months |
| CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF | 6 Months |
| CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF | 12 Months |
| CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF | 24 Months |
| Percentage of Participants Experiencing Adverse Events and Serious Adverse Events | 24 Months |
| Jerusalem |
| Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Tel Aviv Souraski Medical Center | Tel Aviv | 6423906 | Israel |
| Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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