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

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:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Pioglitazone Pioglitazone hydrochloride Atorvastatin Atorvastatin calcium Peginterferon Alfa-2a Atorvastatin calcium trihydrate

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Pioglitazone Ribavirin Atorvastatin Calcium Peginterferon alfa-2a	Hypoglycemic Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anticholesteremic Agents Hypolipidemic Agents Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016