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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brooke Army Medical Center
• Treatments: Atorvastatin; Atorvastatin Calcium; Peginterferon alfa-2a; Pioglitazone; Ribavirin

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