Overview

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

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir
Criteria
Key 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

Key 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