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A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects

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Trial Profile

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Abacavir/Lamivudine (ABC/3TC) Plus a Third Antiretroviral Agent to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adult Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide (Primary) ; Abacavir/lamivudine/nevirapine
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 19 Jul 2019 Primary endpoint (Percentage of Participants Who Have HIV-1 RNA 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24) has been met, according to results published online in the AIDS.
    • 19 Jul 2019 Efficacy and safety results after of switching regimens were published online in the AIDS.
    • 31 Oct 2018 Results of a pooled analysis assessing the efficacy and safety of E/C/F/TAF by age in NCT02605954 and NCT02616783 study (n=293) presented at the 14th International Congress on Drug Therapy and HIV Infection
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