Loading clinical trials...

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

NCT02073656•Gilead Sciences

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 childbearing potential or sexually active male

Exclusion Criteria

•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

Locations (41)

Birmingham, Alabama, United States

Los Angeles, California, United States

Newport Beach, California, United States

Palo Alto, California, United States

Sacramento, California, United States

San Diego, California, United States

San Francisco, California, United States

Torrance, California, United States

Denver, Colorado, United States

Washington D.C., District of Columbia, United States

Key Dates

Start Date

February 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

December 1, 2015

Last Updated

November 16, 2018

Enrollment

335

ACTUAL participants

Conditions

Hepatitis C VirusHIV

Interventions

LDV/SOF

DRUG

RBV

DRUG

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

View study

RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

View study

RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption