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COMPLETEDPHASE2

Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection

A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Randomized Study to Investigate the Effect of Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection

NCT02219685•Gilead Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
•Chronic genotype 1 HCV infection
•Screening laboratory values within defined thresholds
•Use of protocol-specified method(s) of contraception if female of childbearing potential or sexually active male

Exclusion Criteria

•Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol. Current or prior history of any of the following:
•* Hepatic decompensation
•* Solid organ transplantation
•* Significant pulmonary or cardiac disease
•* Chronic liver disease of a non-HCV etiology
•* Hepatocellular carcinoma (HCC)
•* Infection with hepatitis B virus (HBV)
•* Infection with human immunodeficiency virus (HIV)
•* History of recent epilepsy (within 2 years of screening) or cerebral vascular accident (CVA)
•* Structural brain damage
+4 more criteria

Locations (1)

Boston, Massachusetts, United States

Key Dates

Start Date

August 1, 2014

Primary Completion Date

August 1, 2015

Completion Date

April 1, 2016

Last Updated

November 16, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus Infection

Interventions

LDV/SOF

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Screening, Treatment, and Eradication of Hep C

Pharmacokinetics of Sofosbuvir/Daclatasvir in HCV-infected Lactating Women

HCV Reinfection After DAA Therapy in PWID in Belgium

Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso