Status:
COMPLETED
Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Hepatitis c
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 n...
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 hep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00926614
Start Date
September 1 2008
End Date
December 1 2011
Last Update
February 14 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brooke Army Medical Center
San Antonio, Texas, United States, 78234