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

Primary Purpose

Hepatitis c

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pioglitazone (Actos)
atorvastatin (Lipitor)
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis c focused on measuring GT1, HCV, non responder, relapser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brooke Army Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pioglitizone and Atorvastatin

Arm Description

Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2009
Last Updated
February 13, 2012
Sponsor
Brooke Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00926614
Brief Title
Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 not responded or relapsed on standard pegylated interferon and ribavirin therapy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis c
Keywords
GT1, HCV, non responder, relapser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitizone and Atorvastatin
Arm Type
Experimental
Arm Description
Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin
Intervention Type
Drug
Intervention Name(s)
pioglitazone (Actos)
Other Intervention Name(s)
Actos
Intervention Description
pioglitazone 30 mg qd for 30 days, then increase to 45 mg
Intervention Type
Drug
Intervention Name(s)
atorvastatin (Lipitor)
Other Intervention Name(s)
Lipitor
Intervention Description
atorvastatin 40 mg for 30 days then increase to 80 mg daily
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen A Harrison, MD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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