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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707472
• Other study ID #: GS-US-321-0107
• Status: Completed
• Phase: Phase 2
• Start date: October 4, 2012
• Est. completion date: October 17, 2014

Study information

• Verified date: October 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 17, 2014
• Est. primary completion date: October 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coinfection
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV
• HIV/HCV Co-infection
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Biological:
• Simtuzumab
700 mg intravenously for a total of 12 infusions.

Locations

Country	Name	City	State
United States	NIH Department of Laboratory Medicine	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Gilead Sciences	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Han MAT, Gharib AM, Zhao X, Sinkus R, Rizvi BS, Matthews L, et al. Noninvasive Measures of Severity in Chronic Liver Disease, Moving Beyond Fibrosis [Abstract Sa1006]. Digestive Disease Week; 2015 16-19 May; Washington, D.C.

Meissner EG, McLaughlin M, Matthews LA, Kanwar B, Bornstein JD, Kovacs JA, et al. Longitudinal hepatic and PBMC gene expression profiling of HIV and/or HCV-infected patients with advanced liver disease treated with simtuzumab, an anti-LOXL2 antibody [Abstract 448]. Hepatology AASLD Abstracts 2014;60 Number 4 (Suppl):421A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events		First dose date up to Week 24 plus 30 days
Secondary	Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at 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
Secondary	Change From Baseline in HVPG at Week 24		Baseline; Week 24
Secondary	Change From Baseline in MQC at Week 24		Baseline; Week 24
Secondary	Change From Baseline in Alpha SMA at Week 24		Baseline; Week 24
Secondary	Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24		Baseline; Week 24