ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00926614
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Stephen A Harrison, Brooke Army Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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
Go to 
Top of Page 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    Key Record Dates
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