A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Trial Profile

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected 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) ; Atazanavir; Atazanavir/cobicistat; Cobicistat; Cobicistat/darunavir; Darunavir; Emtricitabine/tenofovir disoproxil fumarate; Lamivudine/abacavir; Ritonavir
  • Indications HIV-1 infections
  • Focus Pharmacodynamics; Registrational
  • 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.
    • 13 Jul 2017 The company's MAA for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency (EMA), according to a Gilead Sciences media release. The MAA was supported by data from this and 3 other phase III trials.
    • 12 Jun 2017 According to a Gilead Sciences media release, the company plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.
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