We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01707472
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : December 16, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Liver Fibrosis Hepatitis C HIV HIV/HCV Co-infection Biological: Simtuzumab Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Change in portal pressure gradient before and after treatment [ Time Frame: Baseline to Week 24 ]
    Transjugular liver biopsy with hepatic veinous pressure gradient (HVPG) measurement.

  2. Change in liver fibrosis stage as seen on liver biopsy before and after treatment [ Time Frame: Baseline to Week 24 ]
    Transjugular liver biopsy with hepatic veinous pressure gradient (HVPG) measurement

  3. Change in liver fibrosis as estimated by magnetic resonance (MR) elastography before and after treatment [ Time Frame: Baseline to Week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707472


Locations
United States, Maryland
NIH Department of Laboratory Medicine
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Director: Bittoo Kanwar, MD Gilead Sciences
More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01707472     History of Changes
Other Study ID Numbers: GS-US-321-0107
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: November 2015

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

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