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A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs Study (Co-infection Treatment With Single Tablet Antiviral Regimens)

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Trial Profile

A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs Study (Co-infection Treatment With Single Tablet Antiviral Regimens)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary) ; Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide; Emtricitabine/rilpivirine/tenofovir alafenamide
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms Co-STARs
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 27 Oct 2017 Results presented at the 16th European AIDS Conference
    • 04 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 02 Aug 2017 Planned End Date changed from 29 Sep 2017 to 1 Oct 2017.
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