Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Hepatitis c | Drug: pioglitazone (Actos) Drug: atorvastatin (Lipitor) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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 ]
| 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, Texas | |
| Brooke Army Medical Center | |
| San Antonio, Texas, United States, 78234 | |
| Principal Investigator: | Stephen A Harrison, MD | Brooke Army Medical Center |
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 Submitted: | June 22, 2009 |
| First Posted: | June 23, 2009 |
| 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 |