HCV Treatment With Fluvastatin, Simvastatin to Improve Interferon Sensitivity
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Investigator-initiated Pilot Study Using Statins to Improve the Anti-HCV Response to Peginterferon Alfa 2-b and Ribavirin in Previous Non-responders|
- Improvement in peginterferon response as measured by change in HCV RNA levels [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]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.
- The response of interferon stimulated genes [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2012|
|Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377909
|United States, Oklahoma|
|Veterans Administration Medical Center (VAMC)|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Ted Bader, M.D.||VA Office of Research and Development|