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- GS-US-380-4030: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/ Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV‑1 Infected Subjects who are Virologically Suppressed
Clinical Trial
GS-US-380-4030: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/ Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV‑1 Infected Subjects who are Virologically Suppressed
this study will look at HIV-0positive adults who switch from their current anti-HIV treatment. It will evaluate how safe, effective, and tolerable a new combinatino pill for HIV treatment is compared to another regimen already available by prescription.
Eligibility Criteria
- Inclusion: 1. Adults at least 18 years old who are HIV-positive, and on stable HIV therapy for at least 6 months. 2. HIV count less than 50 for at least 6 months. 3. Lab tests within study-specified ranges. Exclusion: 1. No current or past medical conditions not allowed by the study. 2. No requirement to take medications not allowed by the study. 3. Women cannot be pregnant or breastfeeding.
RESEARCH. INNOVATION. DISCOVERY.