A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2017

At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir/dolutegravir/lamivudine
  • Indications HIV-1 infections
  • Focus Registrational; 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.
    • 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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