Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Summary
The primary objectives of this study are to evaluate the effect of sustained virologic response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS) and on neurocognition as measured by neurocognitive tests. This study will also evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults. During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit, participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12 weeks.
Timeline
- Start
- 2014-08
- Primary completion
- 2015-08
- Completion
- 2016-04
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Blinded Phase: LDV/SOF vs Blinded Phase: Placebo; p = 0.58; t-test, 2 sided; NCT02219685 ↗
registry analysis (superiority or other test); Blinded Phase: LDV/SOF vs Blinded Phase: Placebo; p = 0.0795; ANCOVA; NCT02219685 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ledipasvir/Sofosbuvir | Unknown | — | Oral |