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

Phase 4

Completed

• Conditions: Hepatitis c
• Interventions: Drug: pioglitazone (Actos); Drug: atorvastatin (Lipitor)

• Registration Number: NCT00926614
• Lead Sponsor: Brooke Army Medical Center

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-22
• Study First Posted: 2009-06-23
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pioglitizone and Atorvastatin	pioglitazone (Actos)	Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin
Pioglitizone and Atorvastatin	atorvastatin (Lipitor)	Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States