At a glance
ClinicalIndex Comparison Record- ✓Chronic HCV genotype 1 infection, treatment-naive or prior IFN +/- RBV +/- PI exposure only (no prior NS5A/NS5B DAAs except boceprevir, telaprevir, simeprevir)
- ✓Compensated cirrhosis allowed only if HCV treatment-naive
- ✓Currently on stable ARV regimen (2 NRTI + third agent) unchanged for ≥6 months prior to screening
- ✓Plasma HIV-1 RNA <50 copies/mL for ≥6 months preceding screening, and at screening visit
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating E/C/F/TAF, F/R/TAF, and 1 other intervention for HIV-1 Infection and HCV Infection. Completed, enrolled 150 participants across 43 sites in 2 countries.
Detailed Summary
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants.
Study Details
Timeline
Interventions
150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily
200/25/25 mg FDC tablet administered orally once daily
90/400 mg FDC tablet administered orally once daily