Pioglitazone on Viral Kinetics, Cytokines and Innate Immunity in Insulin Resistant CHC GT 1 Subjects

February 13, 2012 updated by: Stephen A Harrison, Brooke Army Medical Center

Assessment of the Efficacy of Pioglitazone on Viral Kinetics, Cytokines, and Innate Immunity in a Group of Insulin Resistant, Treatment Naïve, Chronic Hepatitis C, Genotype 1 Patients

The purpose of this study is to determine if rosiglitazone, a medicine used to treat diabetes, improves response to anti-viral treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study will be to determine if an insulin sensitizing thiazolidinedione (TZD) improves (1) baseline viremia, (2) enhances viral kinetics, (3) improves cytokine profiles and (4) up regulates innate cellular immunity (presumably adaptive immunity is up regulated as well) as measured by the bioactivity of the collected biomarkers.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HCV-Ab or HCV-RNA by PCR Positive for at least six months (to rule out acute seroconversion)
  • Serum positive for HCV-RNA by PCR assay
  • Must have insulin resistance, defined as a QUICKI score < 0.35. QUICKI
  • Liver biopsy consistent with CHC within 24 months prior to enrollment

  • Compensated liver disease with the following minimum hematological, biochemical, and serologic criteria at the Screening Visit (WNL = within normal limits):

    • Hemoglobin values of >12 gm/dL for females and >13 gm/dL for males.
    • WBC >3,000/ mm3
    • Neutrophil count > 1,500/mm3
    • Platelets >65,000/ mm3
    • Direct bilirubin, within 20% of ULN
    • Indirect bilirubin, within normal limits (WNL)
    • Albumin >3gm/dL
    • Serum creatinine < 20% above the ULN
    • TSH WNL
    • Alpha fetoprotein value < 100 ng/mL

Exclusion Criteria:

  • Prior interferon based therapy
  • Use of insulin
  • Fasting glucose levels > 200 mg/dl
  • Women who are pregnant or breast-feeding
  • No other thiazolidinedione after liver biopsy and/or during the entire study (
  • Hepatitis C of non-genotype 1
  • Suspected hypersensitivity to pioglitazone

  • Any cause for liver disease other than chronic hepatitis C, insulin resistance, or NAFLD, including but not limited to:

    • Hemochromatosis
    • Alpha-1 antitrypsin deficiency
    • Co-infection with HBV
    • Wilson's disease
    • Autoimmune hepatitis
    • Significant alcohol use
    • Drug-related liver disease
  • Any condition that would prevent the subject from having a liver biopsy.
  • Hemoglobinopathies that could potentially compromise patient safety
  • Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy.
  • Participants with organ transplants other than cornea and hair transplant.

  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:

    • Preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded
    • Substance abuse, such as alcohol, IV drugs and inhaled drugs
    • Alcohol consumption is to be strongly discouraged
    • Seizure disorders not controlled with medication
    • Significant cardiovascular dysfunction within the past 12 months
    • Chronic pulmonary disease with documented pulmonary hypertension
    • Immunologically mediated disease [e.g., inflammatory bowel disease (Crohn's disease, ulcerative colitis)], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosis, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis
  • Any medical condition requiring, or likely to require, chronic systemic administration of steroids during the course of the study
  • Evidence of an active or suspected cancer or a history of malignancy where the risk of reoccurrence is ≥ 20% within two years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pioglitazone
Treatment with pioglitazone 45 mg a day for 3 months
Drug: Pioglitazone (Actos)
pioglitazone 45 mg a day
No Intervention: No intervention
Monitoring period without pioglitazone for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in baseline viremia and viral kinetics, and/or pro-inflammatory cytokines decrease, and/or markers of innate immunity are upregulated to position a more favorable response to current CHC therapy.
Time Frame: 104 days
104 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

The Geneva Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2006.152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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