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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Hepatitis c	Drug: pioglitazone (Actos); Drug: atorvastatin (Lipitor)	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy
Study Start Date :	September 2008
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Pioglitizone and Atorvastatin; Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin	Drug: pioglitazone (Actos); pioglitazone 30 mg qd for 30 days, then increase to 45 mg; Other Name: Actos Drug: atorvastatin (Lipitor); atorvastatin 40 mg for 30 days then increase to 80 mg daily; Other Name: Lipitor

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78234

Sponsors and Collaborators

Brooke Army Medical Center

Investigators

Principal Investigator:	Stephen A Harrison, MD	Brooke Army Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stephen A Harrison, Principal Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT00926614 History of Changes
Other Study ID Numbers:	C.2008.153
First Posted:	June 23, 2009
Last Update Posted:	February 14, 2012
Last Verified:	February 2012

Keywords provided by Stephen A Harrison, Brooke Army Medical Center:

GT1; HCV; non responder; relapser

Additional relevant MeSH terms:

Hepatitis; Hepatitis C; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Ribavirin; Atorvastatin Calcium; Peginterferon alfa-2a; Pioglitazone	Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors; Hypoglycemic Agents; Physiological Effects of Drugs