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A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

Trial Profile

A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2018

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At a glance

  • Drugs Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide (Primary) ; Darunavir
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 06 Oct 2016 Primary endpoint (Percentage of participants with HIV-1 RNA < 50 copies/mL at week 24 using the US FDA-defined snapshot algorithm-full analysis set), has been met.
    • 06 Oct 2016 Results of this study, published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).
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