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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01707472
First received: September 11, 2012
Last updated: October 27, 2014
Last verified: October 2014

September 11, 2012
October 27, 2014
August 2012
October 2014   (final data collection date for primary outcome measure)
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
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
Complete list of historical versions of study NCT01707472 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Phase 2a Study of Simtuzumab in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis
A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis

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).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Fibrosis
  • Hepatitis C
  • HIV
  • HIV/HCV Co-infection
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 Patients
    HIV-infected participants will receive simtuzumab every 2 weeks for 24 weeks while continuing on standard therapy for HIV.
    Intervention: Biological: Simtuzumab
  • Experimental: Simtuzumab in HCV Patients
    HCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks.
    Intervention: Biological: Simtuzumab
  • 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.
    Intervention: Biological: Simtuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2014
October 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01707472
GS-US-321-0107
No
Gilead Sciences
Gilead Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Study Director: Bittoo Kanwar, MD Gilead Sciences
Gilead Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP