Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
- Registration Number
- NCT00487318
- Lead Sponsor
- Bader, Ted, M.D.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Not previously treated.
- Off alcohol and marijuana for 6 months
- HCV RNA positive
Exclusion Criteria
- HIV positive
- Advanced liver disease
- Advanced cardiopulmonary disease
- Chronic renal failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Plus statin fluvastatin The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin. 2 standard of care Administration of the standard of care for hepatitis C of peginterferon and ribavirin.
- Primary Outcome Measures
Name Time Method Sustained Viral response 72 weeks
- Secondary Outcome Measures
Name Time Method Viral load at 4, 12 and 24 weeks 24 weeks
Trial Locations
- Locations (1)
Veterans Administration Medical Center
🇺🇸Oklahoma City, Oklahoma, United States