A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 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:
NCT01667731
First received: August 9, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2 and 3 HCV-infection who are co-infected with HIV-1. A total of 230 (115 GT 2/3 and 115 GT1) HIV-1/HCV co-infected subjects will be enrolled into one of 3 treatment regimens depending on their genotype and prior HCV treatment history.

Subjects will be treated with oral GS-7977 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include Genotype 1, 2, and 3 treatment naive subjects (including IFN ineligible) and Genotype 2 and 3 treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.


Condition Intervention Phase
Hepatitis C,
Human Immunodeficiency Virus
Drug: GS-7977 + Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: 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 GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 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:
  • Efficacy of GS-7977 + Ribavirin (RBV) [ Time Frame: 12 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]
    To determine the efficacy of treatment with GS-7977 + ribavirin (RBV) by proportion of subjects with sustained viral response 12 weeks (SVR 12) after discontinuation of therapy

  • Safety and Tolerability of GS-7977 + Ribavirin (RBV) measured by review of accumulated safety data. [ Time Frame: Safety and tolerability on treatment and 30 days post last dose ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of GS-7977 + Ribavirin(RBV) as assessed by review of the accumulated safety data


Secondary Outcome Measures:
  • Sustained Viral Response at 4 weeks and 24 weeks (SVR4 and SVR 24) [ Time Frame: 4 and 24 weeks after discontinuation of therapy ] [ Designated as safety issue: No ]
    To determine the proportion of subjects who attain sustained viral response (SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)

  • Kinetics of circulating HCV RNA during and after treatment discontinuation [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    On treatment and post treatment HCV RNA levels over time will be used to characterize the kinetics of circulating HCV RNA during and after treatment discontinuation

  • Emergence of Viral Resistance measured by patients with viral resistance. [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS-7977 during treatment and after treatment discontinuation


Estimated Enrollment: 230
Study Start Date: July 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-7977 + Ribavirin
230 HIV-1/HCV co-infected subjects will be enrolled and treated with oral GS-7977 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 or 24 weeks based on genotype and treatment experience.
Drug: GS-7977 + Ribavirin
GS-7977: 400mg Ribavirin (RBV): 1000 or 1200 mg/day weight based 12 or 24 week duration

  Eligibility

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

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

  1. Willing and able to provide written informed consent
  2. Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
  3. HCV RNA > 1 x 104 IU/mL at Screening
  4. Infection with HCV genotype 1, 2 or 3 as determined at Screening
  5. HIV-1 infection confirmed with positive ELISA or Western blot at Screening
  6. The subject's medical records must be sufficient to be categorized on IFN eligibility or prior treatment history with PEG/RBV.
  7. Confirmation of chronic HCV infection
  8. Ability to determine presence/absence of cirrhosis.
  9. HIV antiretroviral therapy (ARV) criteria of one of the following:

    • ARV untreated with a CD4 T-cell count >500 cells/mm3
    • On a stable, protocol-approved, ARV for >8 weeks prior to Screening with a CD4 T-cell count >200 cells/mm3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the Screening visit
  10. Approved HIV antiretroviral medications based on drug interaction studies
  11. Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
  12. Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
  13. Male subjects who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
  14. Subject must be of generally good health as determined by the Investigator.
  15. Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

  1. Non-genotype 1/2/3 or mixed genotype at Screening
  2. Genotype 1 with prior treatment for HCV
  3. Poor control with ARV regimen
  4. Prior exposure to a direct-acting antiviral targeting the HCV NS5B polymerase
  5. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  6. A new AIDS-defining condition diagnosed within 30 days prior to screening
  7. Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Baseline
  8. Infection with hepatitis B virus (HBV)
  9. Contraindication to RBV therapy
  10. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
  11. History of solid organ transplantation or malignancy diagnosed or treated within 5 years
  12. Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667731

  Show 27 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Anuj Gaggar Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01667731     History of Changes
Other Study ID Numbers: GS-US-334-0123
Study First Received: August 9, 2012
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
Chronic
HCV
HIV
Human Immunodeficiency Virus
Co-Infected

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Virus Diseases
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 March 03, 2013