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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen A Harrison, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00926614
First received: June 22, 2009
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Hepatitis c
 Drug: pioglitazone (Actos)
Drug: atorvastatin (Lipitor)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 22, 2009
Last Updated: February 13, 2012
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
GT1
HCV
non responder
relapser

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Atorvastatin
 Pioglitazone
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 22, 2013