Trial Profile
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-Naive Adults
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 07 Mar 2018
At a glance
- Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir/dolutegravir/lamivudine
- Indications HIV-1 infections
- Focus Therapeutic Use
- Sponsors Gilead Sciences
- 07 Mar 2018 Results from studies 1489, 1490, 1878 and 1844 presented at the 25th Conference on Retroviruses and Opportunistic Infections
- 08 Feb 2018 According to a Gilead Sciences media release, Gilead plans to present data from this studies at scientific conferences in 2018.
- 08 Feb 2018 According to a Gilead Sciences media release, based on the data from four phase III trials (Studies 1489, 1490, 1844 and 1878), the U.S. Food and Drug Administration (FDA) has approved Biktarvy, an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults.