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

NCT ID: NCT00926614

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Hepatitis c

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pioglitizone and Atorvastatin

Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin

Group Type: EXPERIMENTAL

pioglitazone (Actos)

Intervention Type: DRUG

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

atorvastatin (Lipitor)

Intervention Type: DRUG

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

Interventions

pioglitazone (Actos)

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

Intervention Type: DRUG

atorvastatin (Lipitor)

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

Intervention Type: DRUG

Other Intervention Names

Actos; Lipitor

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Stephen A Harrison

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen A Harrison, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

Brooke Army Medical Center

San Antonio, Texas, United States

Countries

United States

Other Identifiers

C.2008.153

Identifier Type: -

Identifier Source: org_study_id