Pioglitazone on Viral Kinetics, Cytokines and Innate Immunity in Insulin Resistant CHC GT 1 Subjects

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brooke Army Medical Center
• Collaborator: The Geneva Foundation
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• HCV-Ab or HCV-RNA by PCR Positive for at least six months (to rule out acute seroconversion)

• Serum positive for HCV-RNA by PCR assay

• Must have insulin resistance, defined as a QUICKI score < 0.35. QUICKI

• Liver biopsy consistent with CHC within 24 months prior to enrollment

• Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):

• Hemoglobin values of >12 gm/dL for females and >13 gm/dL for males.

• WBC >3,000/ mm3

• Neutrophil count > 1,500/mm3

• Platelets >65,000/ mm3

• Direct bilirubin, within 20% of ULN

• Indirect bilirubin, within normal limits (WNL)

• Albumin >3gm/dL

• Serum creatinine < 20% above the ULN

• TSH WNL

• Alpha fetoprotein value < 100 ng/mL

Exclusion Criteria:

• Prior interferon based therapy

• Use of insulin

• Fasting glucose levels > 200 mg/dl

• Women who are pregnant or breast-feeding

• No other thiazolidinedione after liver biopsy and/or during the entire study (

• Hepatitis C of non-genotype 1

• Suspected hypersensitivity to pioglitazone

• Any cause for liver disease other than chronic hepatitis C, insulin resistance, or NAFLD, including but not limited to:

• Hemochromatosis

• Alpha-1 antitrypsin deficiency

• Co-infection with HBV

• Wilson's disease

• Autoimmune hepatitis

• Significant alcohol use

• Drug-related liver disease

• Any condition that would prevent the subject from having a liver biopsy.

• Hemoglobinopathies that could potentially compromise patient safety

• Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.

• Participants with organ transplants other than cornea and hair transplant.

• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:

• Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded

• Substance abuse, such as alcohol, IV drugs and inhaled drugs

• Alcohol consumption is to be strongly discouraged

• Seizure disorders not controlled with medication

• Significant cardiovascular dysfunction within the past 12 months

• Chronic pulmonary disease with documented pulmonary hypertension

• Immunologically mediated disease [e.g., inflammatory bowel disease (Crohn's disease, ulcerative colitis)], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosis, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis

• Any medical condition requiring, or likely to require, chronic systemic administration of steroids during the course of the study

• Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is ≥ 20% within two years