Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis

October 22, 2019 updated by: Gilead Sciences

A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis

The primary objective of this study is to assess the safety and tolerability of simtuzumab (formerly GS-6624) in HIV and/or hepatitis C virus (HCV)-infected adults with evidence of liver fibrosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • NIH Department of Laboratory Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

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

  • HCV-infected individuals 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 individuals 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 antiretroviral therapy (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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
700 mg intravenously for a total of 12 infusions.
Other Names:
  • GS-6624
  • Anti-LOXL2 Monoclonal Antibody
Experimental: Simtuzumab in HCV Patients
HCV-infected participants will receive simtuzumab every 2 weeks for 24 weeks.
Biological: Simtuzumab
700 mg intravenously for a total of 12 infusions.
Other Names:
  • GS-6624
  • Anti-LOXL2 Monoclonal Antibody
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
700 mg intravenously for a total of 12 infusions.
Other Names:
  • GS-6624
  • Anti-LOXL2 Monoclonal Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: First dose date up to Week 24 plus 30 days
First dose date up to Week 24 plus 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Time Frame: Baseline; Week 24
The Ishak fibrosis score measures the degree of liver fibrosis (scarring) and ranges from 0 (best) to 6 (worst). A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Baseline; Week 24
Change From Baseline in HVPG at Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24
Change From Baseline in MQC at Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24
Change From Baseline in Alpha SMA at Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24
Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24
Time Frame: Baseline; Week 24
Baseline; Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2012

Primary Completion (Actual)

October 17, 2014

Study Completion (Actual)

October 17, 2014

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-321-0107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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