Phase 2 N=18 Treatment

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

Liver Fibrosis · Hepatitis C · HIV · HIV/HCV Co-infection

Bottom Line

View on ClinicalTrials.gov: NCT01707472 ↗

Enrolled (actual)

Serious AEs

5.6%

Results posted

Oct 2019

Primary outcome: Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events — 100; 100; 100 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simtuzumab (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events	100; 100; 100	—
SECONDARY Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24	0; 1; 0; 1; 1; 0	—
SECONDARY Change From Baseline in HVPG at Week 24	2; 0; 0	—
SECONDARY Change From Baseline in MQC at Week 24	2.07; -2.54; 1.27	—
SECONDARY Change From Baseline in Alpha SMA at Week 24	4.69; 5.27; 4.50	—
SECONDARY Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24	0.17; 0.09; 0.09	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01707472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.