Study the Relationship Between Obesity and Hepatitis C Replication
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. .
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Randomized, Partially Blinded, Pilot Study of the Effects of Pioglitazone on HCV RNA in Overweight Subjects With Chronic HCV Genotypes 1 or 4 Infection.|
- HCV RNA [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Only in the Pioglitazone group
- HCV RNA [ Time Frame: Day 4 ] [ Designated as safety issue: No ]Only in the Prednisone group
- Serum indicators of insulin resistance (fasting glucose, insulin, lipids and serum retinol binding protein-4); adiponectins and inflammatory cytokines. [ Time Frame: Day 14 (Pioglitazone) and Day 4 (Prednisone) ] [ Designated as safety issue: Yes ]
- ALT and AST [ Time Frame: Day 14 (Pioglitazone) and Day 4 (Prednisone) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Pioglitazone will be taken at a dose of 30 mg for up to 14 days
Other Name: ACTOS
Prednisone will be taken at a dose of 40 mg for up to 4 days
Other Name: PREDNISONE
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157975
|United States, California|
|University of California at San Diego Hospitals|
|San Diego, California, United States, 92037|
|Principal Investigator:||Mario Chojkier, MD||UCSD|
|Principal Investigator:||Martina Buck, PhD||UCSD|
|Principal Investigator:||Hesham Elkhayat, MD||Cairo University, Egypt|