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

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ClinicalTrials.gov Identifier: NCT00926614
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):
Stephen A Harrison, 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.

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 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
Primary Completion Date : June 2011
Study Completion Date : December 2011

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

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 ]

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926614

United States, Texas
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center
Principal Investigator: Stephen A Harrison, MD Brooke Army Medical Center

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    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Atorvastatin Calcium
Peginterferon alfa-2a
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