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

Brooke Army Medical Center20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis c

Interventions

pioglitazone (Actos)DRUG

pioglitazone 30 mg qd for 30 days, then increase to 45 mg

atorvastatin (Lipitor)DRUG

atorvastatin 40 mg for 30 days then increase to 80 mg daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Brooke Army Medical Center

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 36 weeks

Data from ClinicalTrials.gov

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