drugset / Trial / NCT00207402

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

NCT00207402

Phase 4 Completed 34 enrolled Brooke Army Medical Center InterMune · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-10
Primary completion
2010-01
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rosiglitazone Small molecule 4 mg
Background Interferon Alfacon-1 Protein / enzyme biologic 15 ug Subcutaneous
Background Ribavirin Small molecule