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 study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01783678
First received: January 31, 2013
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Human Immunodeficiency Virus
Drug: Sofosbuvir
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of treatment (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  • Incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response at 4 and 24 weeks after discontinuation of treatment (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.

  • Proportion of participants with on-treatment virologic failure [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]

    Virologic failure is defined as either:

    • Virologic breakthrough (participant achieved undetectable HCV RNA levels during treatment but subsequently had detectable HCV RNA while continuing treatment), or
    • Non-response (HCV RNA persistently ≥ 25 IU/mL through 8 weeks of treatment ), or
    • Virologic relapse (HCV RNA ≥ 25 IU/mL during the posttreatment period having achieved HCV RNA < 25 IU/mL at end of treatment), or
    • Rebound (> 1 log10IU/mLincrease in HCV RNA from nadir while on treatment).

  • HCV RNA change from baseline [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sofosbuvir+RBV 12 weeks TN
Treatment naive (TN) participants coinfected with HIV-1 and genotype 2 HCV infection will receive sofosbuvir plus RBV for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
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)
Experimental: Sofosbuvir+RBV 24 weeks TE
Treatment experienced (TE) participants coinfected with HIV-1 and genotypes 2 and 3 HCV infection will receive sofosbuvir plus RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
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)
Experimental: Sofosbuvir+RBV 24 weeks TN
Treatment naive (TN) participants coinfected with HIV-1 and genotypes 1, 3, and 4 HCV infection will receive sofosbuvir plus RBV for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > or = 18 years with chronic HCV genotype 1, 2, 3, or 4 and co-infected with HIV-1 infection
  • HCV RNA > 10,000 IU/mL at Screening
  • HCV treatment-naïve for HCV genotypes 1, 2, 3, or 4
  • Previous HCV treatment for HCV genotypes 2 or 3
  • On a stable, protocol-approved, HIV antiretroviral (ARV) regimen with undetectable HIV-RNA for greater than 8 weeks prior to screening.
  • Not currently receiving HIV ARVs
  • 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 subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783678

Locations
Australia, New South Wales
Darlinghurst, New South Wales, Australia
Sydney, New South Wales, Australia
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
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01783678     History of Changes
Other Study ID Numbers: GS-US-334-0124
Study First Received: January 31, 2013
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Immunologic Deficiency Syndromes
Virus Diseases
Hepatitis C, Chronic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014