Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba

Study Overview
=================
Brief Summary
-----------------
The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

Detailed Description
-----------------
The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin. This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.

Official Title
-----------------
48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy

Conditions
-----------------
Hepatitis c

Intervention / Treatment
-----------------
* Drug: pioglitazone (Actos)
* Drug: atorvastatin (Lipitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GT 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy Insulin resistance Compensated liver disease WBC < 3,000/ mm3 Neutrophil count < 1,500/mm3 Platelets < 65,000/ mm3 Albumin > 3 gm/dL Exclusion Criteria: Participants on metformin or other thiazolidinedione must have 3month wash-out period Women who are pregnant or breast-feeding Males with pregnant partners Co-infection with HAV, HBV, or HIV Ophthalmic abnormalities such as severe retinopathy Poorly controlled thyroid dysfunction Serum creatinine concentration > 1.5 times ULN Severe psychiatric or neuropsychiatric disorders History of alcoholism or drug addiction 1 year prior to screening Seizure disorders not controlled with medication Significant cardiovascular dysfunction within the past 12 months Chronic pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pioglitizone and Atorvastatin<br>Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin | Drug: pioglitazone (Actos)<br>* pioglitazone 30 mg qd for 30 days, then increase to 45 mg<br>* Other names: Actos;Drug: atorvastatin (Lipitor)<br>* atorvastatin 40 mg for 30 days then increase to 80 mg daily<br>* Other names: Lipitor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement is seen in insulin resistance patients to be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin. |  | 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GT1, HCV, non responder, relapser