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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2022

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At a glance

  • Drugs Atazanavir (Primary) ; Atazanavir/cobicistat (Primary) ; Cobicistat (Primary) ; Emtricitabine/tenofovir disoproxil fumarate; Ritonavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 16 Jul 2015 According to BMS media release, atazanavir/cobicistat fixed dose combination (Evotaz) for the treatment of HIV-1 infected patients was approved by US FDA in January 2015.
    • 16 Jul 2015 Results published in the Media Release.
    • 16 Jul 2015 According to BMS media release, atazanavir/cobicistat fixed dose combination (Evotaz) for the treatment of HIV-1 infected patients has been approved by European Commission based on data from this trial.

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