Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin
Genotype 1 hepatitis C virus (HCV) patients who did not respond (did not lose virus during treatment) or relapsed (virus went away on treatment but came back after treatment was stopped) after treatment with at least twelve weeks of a pegylated (long-acting) interferon and ribavirin will be considered for this study. There are two purposes to this study: first, to determine how rosiglitazone, a medicine used to treat diabetes, affects the HCV viral load; and second, to determine if treatment of insulin resistance with rosiglitazone prior to therapy for HCV will improve sustained virologic response (loss of virus that continues beyond six months after completion of HCV therapy) to HCV therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Combination Therapy With Interferon Alfacon1, Ribavirin, & Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, GT 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin|
- There is change in viral kinetics with improvement of insulin sensitivity [ Time Frame: 104 days ] [ Designated as safety issue: No ]
- There is significant improvement in the SVR obtained when treating insulin resistant patients with the insulin sensitizing medication, Avandia, prior to and during treatment with Infergen and ribavirin when compared to Infergen [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Active Comparator: rosiglitazone
Treatment with rosiglitazone 4 mg twice a day for 3 months prior to and during the course of 48 weeks of treatment with interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin.
Infergen 15mcg/ d Avandia qd Ribavirin bid
No Intervention: No Avandia
Monitoring period without rosiglitazone for 3 months prior to 48 weeks of interferon alfacon-1 15mcg/0.5ml SQ daily and weight-based ribavirin
This study will demonstrate the efficacy of treating insulin resistance with rosiglitazone in CHC, genotype 1 patients who have failed previous treatment with pegylated interferon and ribavirin. Pre-treatment with rosiglitazone may become the new standard of care prior to HCV therapy for those patients who are insulin resistant, increasing their chance for achieving an SVR on interferon alfacon-1 combination therapy and decreasing the morbidity and mortality associated with chronic hepatitis C.
|United States, Texas|
|Brooke Army Medical Center|
|Ft. Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Stephen A Harrison, MD||Brooke Army Medical Center|
|Principal Investigator:||Shane Mills, MD||Brooke Army Medical Center|