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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Infection With HIV Co-Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDV/SOF

LDV/SOF FDC for 6 weeks

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

Interventions

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LDV/SOF

90/400 mg FDC tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No