Study the Relationship Between Obesity and Hepatitis C Replication

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-09-30

Brief Summary

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Patients with chronic hepatitis C viral infection (HCV) and with a BMI greater than 25Kg/m2 are refractory to medical treatment. Also, HCV replication seems to be affected when modeling insulin resistance in replicon cell culture systems.

PPARg -agonist (Pioglitazone) is effective in controlling liver inflammation in obese subjects with non-alcoholic steatohepatitis (NASH) and also improving insulin sensitivity. Therefore, we hypothesize that improving insulin resistance and /or inflammation may affect HCV replication and viral kinetics. Independently of PPARg pathways, Prednisone may increase HCV viral kinetics. .

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Detailed Description

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This is a randomized, two arm clinical trial. The investigators performing the primary and secondary endpoints are blinded to subject identifiers and arm identifiers.

Subject's screening for HCV Genotype 4 started in Agouza Hospital in July 2010 and ended in February, 2011. No recruitment has occurred for HCV Genotype 1.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pioglitazone

Group Type EXPERIMENTAL

Pioglitazone

Intervention Type DRUG

Pioglitazone will be taken at a dose of 30 mg for up to 14 days

Prednisone

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Prednisone will be taken at a dose of 40 mg for up to 4 days

Interventions

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Pioglitazone

Pioglitazone will be taken at a dose of 30 mg for up to 14 days

Intervention Type DRUG

Prednisone

Prednisone will be taken at a dose of 40 mg for up to 4 days

Intervention Type DRUG

Other Intervention Names

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ACTOS

Eligibility Criteria

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Inclusion Criteria

* Infection with HCV genotype 1 or 4 (subjects infected with multiple genotypes are not eligible)
* BMI greater than 25 Kg/m2
* HCV-infected subjects naïve to treatment: subjects who either have never been treated for HCV infection or who previously received HCV treatment ending more than 3 months prior to enrollment for not longer than 2 weeks
* Plasma HCV RNA concentration of \>10,000 IU/mL at the screening evaluation

Exclusion Criteria

* Previous intolerance to Pioglitazone, Rosiglitazone, Troglitazone or corticosteroids
* Women who are pregnant or breastfeeding
* History of diabetes mellitus requiring treatment other than diet
* Decompensated liver disease or other known causes of liver disease including, but not limited to autoimmune hepatitis, Wilson's disease, hemochromatosis, primary biliary cirrhosis, schistosomiasis, sclerosing cholangitis, alcohol- or drug-induced liver disease, or alpha-one antitrypsin deficiency
* Concurrent hepatitis B virus (HBV) infection
* Known immunodeficiency disease, autoimmune disorders or active gastrointestinal disease
* Abuse of alcohol or illicit drugs within 6 months before enrollment
* Use of an investigational drug within 4 weeks before the screening visit or during the screening period.
* Use of systemic immunosuppressants
* History of poorly controlled psychiatric disease or poorly controlled pulmonary disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No