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

NCT ID: NCT02219685

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-04-30

Brief 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.

Conditions

Hepatitis C Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LDV/SOF

Participants will receive LDV/SOF FDC for 12 weeks.

Group Type: EXPERIMENTAL

LDV/SOF

Intervention Type: DRUG

90/400 mg FDC tablet administered orally once daily

Placebo

Participants will receive LDV/SOF placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablet administered orally once daily

Open-Label Treatment Phase

Following Posttreatment Week 4, participants in the placebo group will be offered open-label treatment with LDV/SOF FDC for 12 weeks.

Group Type: EXPERIMENTAL

LDV/SOF

Intervention Type: DRUG

90/400 mg FDC tablet administered orally once daily

Interventions

LDV/SOF

90/400 mg FDC tablet administered orally once daily

Intervention Type: DRUG

Placebo

Tablet administered orally once daily

Intervention Type: DRUG

Other Intervention Names

Harvoni®; GS-5885/GS-7977

Eligibility Criteria

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
• Presence of cirrhosis
• Contraindication to MRI
• Pregnant or nursing female
• Prior treatment NS5A directly-acting antiviral agent. Any interferon (IFN)-containing regimen within 8 weeks of Screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benedetta Massetto, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

GS-US-337-1445

Identifier Type: -

Identifier Source: org_study_id