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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

Page last updated: August 23, 2015

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