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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01707472
First received: September 11, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

This is an open label, exploratory study of simtuzumab (GS-6624) in adults infected with HIV, hepatitis C virus (HCV), or co-HIV/HCV with histological evidence of liver fibrosis. Participants will receive simtuzumab 700 mg intravenously 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: Simtuzumab
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:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of adverse events following administration of simtuzumab in HIV and/or Hepatitis C-infected subjects with evidence of liver fibrosis [ Time Frame: Baseline to Week 36 ] [ Designated as safety issue: No ]
    Adverse events (AEs) and clinical laboratory test results will be reported and evaluated up to 14 weeks after the last dose of simtuzumab. 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 to Week 24 ] [ Designated as safety issue: No ]
    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 to Week 24 ] [ Designated as safety issue: No ]
    Transjugular liver biopsy with hepatic veinous pressure gradient (HVPG) measurement

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

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab in HIV Patients
HIV-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV.
Biological: Simtuzumab
Subjects will receive simtuzumab 700 mg intravenously bi-weekly over 24 weeks, for a total of 12 infusions.
Other Names:
  • Anti-LOXL2 Monoclonal Antibody
  • GS-6624
Experimental: Simtuzumab in HCV Patients
HCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks.
Biological: Simtuzumab
Subjects will receive simtuzumab 700 mg intravenously bi-weekly over 24 weeks, for a total of 12 infusions.
Other Names:
  • Anti-LOXL2 Monoclonal Antibody
  • GS-6624
Experimental: Simtuzumab in HIV/HCV Co-Infected Patients
HIV/HCV co-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV.
Biological: Simtuzumab
Subjects will receive simtuzumab 700 mg intravenously bi-weekly over 24 weeks, for a total of 12 infusions.
Other Names:
  • Anti-LOXL2 Monoclonal Antibody
  • GS-6624

  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 sustained virologic response (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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707472

Locations
United States, Maryland
NIH Department of Laboratory Medicine
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Gilead Sciences
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: March 12, 2014
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 July 29, 2014