Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba
Information source: Brooke Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis c
Intervention: pioglitazone (Actos) (Drug); atorvastatin (Lipitor) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Brooke Army Medical Center Official(s) and/or principal investigator(s): Stephen A Harrison, MD, Principal Investigator, Affiliation: Brooke Army Medical Center
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Brooke Army Medical Center, San Antonio, Texas 78234, United States
Additional Information
Starting date: September 2008
Last updated: February 13, 2012
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