HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
- Registration Number
- NCT01377909
- Lead Sponsor
- Bader, Ted, M.D.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description statin statin -
- Primary Outcome Measures
Name Time Method Improvement in peginterferon response as measured by change in HCV RNA levels 48 weeks The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically.
- Secondary Outcome Measures
Name Time Method The response of interferon stimulated genes 48 weeks The number of known interferon activated genes will be assessed by microarray from serum samples at baseline and then reassessed by microarray 48 weeks later.
Trial Locations
- Locations (1)
Veterans Administration Medical Center (VAMC)
🇺🇸Oklahoma City, Oklahoma, United States