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Sponsors and Collaborators: |
The Geneva Foundation InterMune |
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Information provided by: | Brooke Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00207402 |
Genotype 1 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, effects the HCV virus 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.
Condition | Intervention | Phase |
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Hepatitis C |
Drug: Infergen, ribavirin, rosiglitazone |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Trial of Combination Therapy With Interferon Alfacon-1, Ribavirin, and Rosiglitazone in a Group of Insulin Resistant, Chronic Hepatitis C, Genotype 1 Patients Who Are Previous Relapsers or Nonresponders to Pegylated Interferon and Ribavirin |
Estimated Enrollment: | 40 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | March 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):
Exclusion Criteria:
Any cause for liver disease other than chronic hepatitis C, insulin resistance, or non-alcoholic fatty liver disease (NAFLD), including but not limited to:
Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
Contact: Stephen A Harrison, MD | 210-916-5553 | |
Contact: Karol Barstow, BSN RN CCRC | 210-916-5553 | karol.barstow@amedd.army.mil |
United States, Texas | |
Brooke Army Medical Center | |
Ft. Sam Houston, Texas, United States, 78234 |
Principal Investigator: | Shane Mills, MD | Brooke Army Medical Center |
Study ID Numbers: | C2005.143 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00207402 |
Health Authority: | United States: Federal Government |
Hepatitis C Insulin resistance |
Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human Insulin Hepatitis |
Virus Diseases Digestive System Diseases Hepatitis C Insulin Resistance Interferon alfacon-1 Hepatitis C, Chronic Rosiglitazone |
Antimetabolites Anti-Infective Agents RNA Virus Infections Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Flaviviridae Infections |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions |