Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Na�ve Adults
The study will evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Actual Study Start Date: November 13, 2015
Actual Primary Completion Date: May 9, 2017
Estimated Study Completion Date: April 2019
Arm:
- Experimental: Blinded Phase: B/F/TAF
- Active Comparator: Blinded Phase: ABC/DTG/3TC
- Experimental: Open-Label Phase
| Category | Value |
|---|---|
| Date last updated at source | 2017-12-05 |
| Study type(s) | Interventional |
| Expected enrolment | 629 |
| Study start date | 2015-11-13 |
| Estimated primary completion date | 2017-05-09 |