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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

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Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2019

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At a glance

  • Drugs Bictegravir/emtricitabine/tenofovir alafenamide (Primary) ; Dolutegravir (Primary) ; Emtricitabine/tenofovir disoproxil fumarate (Primary)
  • Indications Hepatitis B; HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Alliance
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 10 Apr 2019 Planned End Date changed from 1 Aug 2023 to 1 Mar 2023.
    • 20 Mar 2019 Planned primary completion date changed from 1 Oct 2020 to 1 Mar 2021.
    • 15 Jun 2018 Status changed from not yet recruiting to recruiting.
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