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A Phase 2a Study of GS-6624 in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis

This study is currently recruiting participants.
Verified September 2012 by Gilead Sciences
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01707472
First received: September 11, 2012
Last updated: October 12, 2012
Last verified: September 2012
History of Changes
  Purpose

This is an open label, exploratory study of GS-6624 in adult subjects infected with HIV, HCV, or co-HIV/HCV with histological evidence of liver fibrosis. Subjects will receive 700 mg IV GS-6624 every 2 weeks for a total of 24 weeks (12 infusions) while continuing on standard therapy for HIV (HIV-infected subjects only).


Condition Intervention Phase
Liver Fibrosis
Hepatitis C
HIV
HIV/HCV Co-infection
 Biological: GS-6624
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of adverse events following administration of GS-6624 in HIV and/or Hepatitis C-infected subjects with evidence of liver fibrosis [ Time Frame: 36 Weeks ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) and clinical laboratory test results will be reported and evaluated up to 14 weeks after the last dose of GS-6624. A complete evaluation of safety data will be done when all subjects have completed the study


Secondary Outcome Measures:
  • Change in portal pressure gradient before and after treatment [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    Transjugular liver biopsy with hepatic veinous pressure gradient (HVPG) measurement.

  • Change in liver fibrosis stage as seen on liver biopsy before and after treatment [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    Transjugular liver biopsy with hepatic veinous pressure gradient (HVPG) measurement

  • Change in liver fibrosis as estimated by MR elastography before and after treatment [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-6624 in HIV Patients Biological: GS-6624
Subjects will receive 700 mg IV GS-6624 bi-weekly over 24 weeks, for a total of 12 infusions
Other Name: Anti-LOXL2 Monoclonal Antibody
Experimental: GS-6624 in HCV Patients Biological: GS-6624
Subjects will receive 700 mg IV GS-6624 bi-weekly over 24 weeks, for a total of 12 infusions
Other Name: Anti-LOXL2 Monoclonal Antibody
Experimental: GS-6624 in HIV/HCV Co-Infected Patients Biological: GS-6624
Subjects will receive 700 mg IV GS-6624 bi-weekly over 24 weeks, for a total of 12 infusions
Other Name: Anti-LOXL2 Monoclonal Antibody

  Eligibility

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

Key Inclusion Criteria:

  • HIV-infected subjects must have positive serologies with viral load suppressed below 400 copies/mL

  • HCV-infected subjects must have:

    • Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following:
    • Been null responder to previous pegylated interferon and ribavirin therapy OR
    • Failed to achieve SVR on a regimen containing a direct-acting antiviral (DAA) in addition to pegylated interferon and ribavirin OR
    • Are unwilling to receive or have contraindications to interferon therapy for HCV

  • HIV/HCV co-infected subjects must have:

    • Positive HIV serologies with viral load suppressed below 400 copies/mL
    • Chronic HCV infection with HCV RNA ≥ 2000 IU/ml AND at least 1 of the following:
    • Been null responder to previous pegylated interferon and ribavirin therapy OR
    • Failed to achieve SVR on a regimen containing a direct-acting antiviral (DAA) in addition to pegylated interferon and ribavirin OR
    • Are unwilling to receive or have contraindications to interferon therapy for HCV
  • BMI < 36 kg/m2
  • Willing to allow blood and tissue samples to be stored for future use to study HIV infection, immune function, liver disease and additional mechanisms involved in liver fibrosis among patients with HIV and/or HCV, which may not be related directly to the specific objectives of this study protocol
  • Have a primary care physician

Key Exclusion Criteria:

  • Cause of liver fibrosis other than HCV or long-term ART treatment for HIV
  • Currently being treated for HCV
  • Evidence of active Hepatitis A, B or D infections
  • History or evidence of hepatocellular carcinoma
  • Unwillingness to undergo a liver biopsy pre-treatment and post-treatment, or to undergo all other protocol required tests/procedures or return to the site for required visits
  • Presence of contraindications to magnetic resonance imaging (e.g., presence of any metal in the body, cardiac or neural pacemaker, aneurysm clip, cochlear implant, claustrophobia)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707472

Contacts
Contact: Edward Robbie edward.robbie@gilead.com

Locations
United States, Maryland
NIH Department of Laboratory Medicine Recruiting
Bethesda, Maryland, United States, 20892
Contact: Caryn G Morse, MD, MPH     301-496-6028        
Sponsors and Collaborators
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Director: Bittoo Kanwar, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01707472     History of Changes
Other Study ID Numbers: GS-US-321-0107
Study First Received: September 11, 2012
Last Updated: October 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Liver Fibrosis
Fibrosis
HIV
HCV
 GS-6624
Hepatitis
Hepatitis C

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 03, 2013