NCT01707472CompletedPhase 2
A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)
Outcomes
Primary Outcomes
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: First dose date up to Week 24 plus 30 days
Secondary Outcomes
- Change From Baseline in Alpha SMA at Week 24(Baseline; Week 24)
- Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24(Baseline; Week 24)
- Change From Baseline in HVPG at Week 24(Baseline; Week 24)
- Change From Baseline in MQC at Week 24(Baseline; Week 24)
- Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24(Baseline; Week 24)
Investigators
Study Sites (2)
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