Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Completed
- Conditions
- HIV-1-infection
- Interventions
- Other: B/F/TAF
- Registration Number
- NCT04009057
- 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
- 143
Inclusion Criteria
- HIV-1 infection
- Signed informed consent
- Initiating treatment with B/F/TAF
Exclusion Criteria
- Participation in any interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description B/F/TAF B/F/TAF HIV-1 infected adults who initiate B/F/TAF therapy
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 CD4/CD8 Ratio 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 12 Months After Initiating or Switching to B/F/TAF 12 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 24 Months After Initiating or Switching to B/F/TAF 24 Months 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 CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF 3 Months Percentage of Participants Experiencing Adverse Events and Serious Adverse Events 24 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 CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF 12 Months CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF 6 Months
Trial Locations
- Locations (5)
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Tel Aviv Souraski Medical Center
🇮🇱Tel Aviv, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Rambam Medical Center
🇮🇱Haifa, Israel