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

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: 10 Aug 2017

At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir/dolutegravir/lamivudine
  • Indications HIV-1 infections
  • Focus Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 10 Aug 2017 According to a Gilead Sciences media release, the US FDA has granted priority review for the company's NDA for BIC/FTC/TAF, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of February 12, 2018.
    • 24 Jul 2017 According to a Gilead Sciences media release, results were presented at the 9th IAS Conference on HIV Science (IAS 2017).
    • 24 Jul 2017 Results published in the Gilead Sciences Media Release.
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