NCT00207402

Infergen, Ribavirin & Avandia in Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	rosiglitazone	Infergen 15mcg/ d Avandia qd Ribavirin bid

Timeline

• Start date: 2005-10-01
• Primary completion: 2010-01-01
• Completion: 2010-07-01
• First posted: 2005-09-21
• Last updated: 2012-02-14

Locations

1 site across 1 country: United States