Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Gilead Sciences0 sites26 target enrollmentJune 2015

ConditionsHepatitis C Infection With HIV Co-Infection

InterventionsLDV/SOF

DrugsLDV/SOF

Overview

Phase: Phase 2
Intervention: LDV/SOF
Conditions: Hepatitis C Infection With HIV Co-Infection
Sponsor: Gilead Sciences
Enrollment: 26
Primary Endpoint: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

January 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
•Confirmed HIV-1 infection
•CD4 T cell count \>200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count \> 500/μL at screening for individuals without ART
•Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

Exclusion Criteria

•Pregnant or nursing female or male with pregnant female partner
•Chronic liver disease of a non HCV etiology
•Coinfection with hepatitis B virus (HBV)
•Treatment with any investigational drug or device within 60 days of the screening visit.
•History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
•Note: Other protocol defined Inclusion/Exclusion criteria may apply

Arms & Interventions

LDV/SOF

LDV/SOF FDC for 6 weeks

Intervention: LDV/SOF

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)

Time Frame: Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time Frame: Up to 6 weeks

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)(Posttreatment Week 4)
Percentage of Participants With HCV RNA < LLOQ on Treatment(Weeks 2, 4, and 6)
Change From Baseline in HCV RNA at Weeks 2, 4, and 6(Baseline; Weeks 2, 4, and 6)
Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)
Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.(Day 1; Week 6)
Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4(Weeks 2, 4, 6, and Posttreatment Week 4)
Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4(Baseline; Week 6; Posttreatment Week 4)