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

Phase

Condition

Hiv

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT02073656

GS-US-337-0115

Ages > 18
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 childbearingpotential or sexually active male

Exclusion

Exclusion Criteria:

Clinically-significant illness (other than HCV or HIV) or any other major medicaldisorder that may interfere with subject treatment, assessment, or compliance with theprotocol
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

Study Design

February 01, 2014

December 31, 2015

Connect with a study center

Vancouver, British Columbia V6Z 1Y6
Canada
Site Not Available
Ottawa, Ontario K1H 8L6
Canada
Site Not Available
Toronto, Ontario M5G 2N2
Canada
Site Not Available
Montreal, Quebec H2L 5B1
Canada
Site Not Available
Auckland, 1142
New Zealand
Site Not Available
Christchurch, 8011
New Zealand
Site Not Available
San Juan, 00936-5607
Puerto Rico
Site Not Available
Birmingham, Alabama 35294-2170
United States
Site Not Available
Los Angeles, California 90027
United States
Site Not Available
Newport Beach, California 92663
United States
Site Not Available
Palo Alto, California 94304-5350
United States
Site Not Available
Sacramento, California 95817
United States
Site Not Available
San Diego, California 92103
United States
Site Not Available
San Francisco, California 94110
United States
Site Not Available
Torrance, California 90502
United States
Site Not Available
Denver, Colorado 80209
United States
Site Not Available
Washington, District of Columbia 20815
United States
Site Not Available
Bradenton, Florida 34209
United States
Site Not Available
Miami, Florida 33136
United States
Site Not Available
Orlando, Florida 32803
United States
Site Not Available
Tampa, Florida 33614
United States
Site Not Available
Atlanta, Georgia 30312
United States
Site Not Available
Decatur, Georgia 30033
United States
Site Not Available
Chicago, Illinois 60612
United States
Site Not Available
Lutherville, Maryland 21093
United States
Site Not Available
Boston, Massachusetts 02115
United States
Site Not Available
Kansas City, Missouri 64111
United States
Site Not Available
Santa Fe, New Mexico 87505
United States
Site Not Available
Bronx, New York 10468
United States
Site Not Available
New York, New York 10065
United States
Site Not Available
Chapel Hill, North Carolina 27599
United States
Site Not Available
Durham, North Carolina 27710
United States
Site Not Available
Cincinnati, Ohio 45267-0595
United States
Site Not Available
Allentown, Pennsylvania 18102
United States
Site Not Available
Philadelphia, Pennsylvania 19107
United States
Site Not Available
Providence, Rhode Island 02906
United States
Site Not Available
Dallas, Texas 75235
United States
Site Not Available
Houston, Texas 77004
United States
Site Not Available
Annandale, Virginia 22003
United States
Site Not Available
Richmond, Virginia 23298-0341
United States
Site Not Available
Seattle, Washington 98104
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.