Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection

Completed · Phase 3

Conditions studied: Hepatitis C Virus, HIV

In brief

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.

Key facts

Study ID

NCT02073656

Run by

Gilead Sciences

People needed

335

Starts

2014-02-01

Expected to finish

2015-12-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCV RNA ≥ 10,000 IU/mL at screening
• HCV genotype 1 or 4
• HIV-1 infection
• Cirrhosis determination, a fibroscan or liver biopsy may be required
• Screening laboratory values within defined thresholds
• Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male

You may not qualify if…

• Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
• Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
• Hepatitis B virus (HBV) infection
• Pregnant or nursing female
• Chronic use of systemically administered immunosuppressive agents

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Palo Alto, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Lutherville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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