A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

April 15, 2015 updated by: Gilead Sciences

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

275

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
      • Sydney, New South Wales, Australia
    • Victoria
      • Melbourne, Victoria, Australia
      • Parkville, Victoria, Australia
  • France
      • Lyon, France
      • Nice, France
      • Paris, France
  • Germany
      • Berlin, Germany
      • Bonn, Germany
      • Duesseldorf, Germany
      • Frankfurt, Germany
      • Hamburg, Germany
      • Würzburg, Germany
  • Italy
      • Bergamo, Italy
      • Milano, Italy
      • Napoli, Italy
      • Rome, Italy
      • Torino, Italy
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Seville, Spain
  • United Kingdom
      • Glasgow, United Kingdom
      • London, United Kingdom
      • Sussex, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
  • HCV RNA > 10,000 IU/mL at screening

  • HCV treatment history:

    • Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
    • Treatment-experienced for HCV genotypes 2 or 3

  • HIV antiretroviral (ARV) criteria:

    • On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or
    • ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3
  • Presence or absence of cirrhosis; a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

  • HCV genotype 1 or 4 with previous HCV treatment
  • Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
  • A new AIDS-defining condition diagnosed within 30 days prior to screening
  • Prior use of any other inhibitor of the HCV NS5B polymerase
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • Chronic hepatitis B virus (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents
  • Clinically relevant drug or alcohol abuse within 12 months of screening
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genotype 2 treatment-naive
Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: Genotype 2/3 treatment-experienced
Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Experimental: Genotype 1/3/4 treatment-naive
Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Up to 24 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Up to 24 weeks
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
Posttreatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
Posttreatment Weeks 4 and 24
HCV RNA Change From Baseline at Week 1
Time Frame: Baseline; Week 1
Baseline; Week 1
HCV RNA Change From Baseline at Week 2
Time Frame: Baseline; Week 2
Baseline; Week 2
HCV RNA Change From Baseline at Week 4
Time Frame: Baseline; Week 4
Baseline; Week 4
HCV RNA Change From Baseline at Week 6
Time Frame: Baseline; Week 6
Baseline; Week 6
HCV RNA Change From Baseline at Week 8
Time Frame: Baseline; Week 8
Baseline; Week 8
Percentage of Participants Experiencing Virologic Failure
Time Frame: Baseline up to Posttreatment Week 24

On-treatment virologic failure was defined as either:

  • Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
  • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
  • Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).

Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."
Baseline up to Posttreatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-334-0124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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