A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2017

At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Dolutegravir; Emtricitabine/tenofovir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms INFE 5305
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 31 Aug 2017 Results published in The Lancet.
    • 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.
    • 26 Jul 2017 Results assessing 48-week efficacy and safety of the trial, presented at the 9th International AIDS Society Conference on HIV Science..
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