Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.|
- Sustained Viral response [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
- Viral load at 4, 12 and 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm 1 Plus statin
The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin.
Add fluvastatin at 20-40 mg/day to standard of care
Other Name: Lescol
Active Comparator: 2
Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
Drug: standard of care
|United States, Oklahoma|
|Veterans Administration Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Ted F Bader, MD||OUHSC and VAMC|