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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2017

At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary) ; Emtricitabine/rilpivirine/tenofovir alafenamide
  • Indications Hepatitis C; HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Co-STARs
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 02 Aug 2017 Planned End Date changed from 29 Sep 2017 to 1 Oct 2017.
    • 02 Aug 2017 Planned primary completion date changed from 31 Aug 2017 to 1 Sep 2017.
    • 26 Jan 2017 Status changed from recruiting to active, no longer recruiting.
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