HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective: The goal is to improve peginterferon sensitivity in previous poor responders. "Sensitivity" here means the host's ability to kill more HCV.

Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bader, Ted, M.D.
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Interferons; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening

Exclusion Criteria:

• decompensated liver disease

• severe cardiac disease (ejection fraction < 20% or uncontrolled angina)

• unexplained muscle pain at time of screening

• pregnancy

• renal insufficiency (creatine clearance < 50 ml/min)