Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections
Status:
Terminated
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in
patients with HIV and hepatitis C virus (HCV) infections. Fatty liver and accompanying
insulin resistance in patients with HIV and HCV co-infections is associated with inflammatory
changes, liver fibrosis and a poorer response to HCV treatment. Pioglitazone is a drug that
helps to reduce the body's resistance to insulin. It is approved by the Food and Drug
Administration to treat diabetes.
Patients with HIV and HCV co-infections who have hepatic steatosis (fatty liver) may be
eligible for this study. Candidates are screened with a medical history and physical
examination, blood and urine tests, magnetic resonance imaging (MRI) of the liver to measure
liver fat and, if needed, a liver biopsy to confirm the diagnosis of liver steatosis.
- Participants are randomly assigned to take either pioglitazone therapy or placebo for 48
weeks. This is followed by a second 48-week treatment period in which all participants
take pioglitazone.
- There are approximately 12 visits during the 96 weeks of the study. Participants will
receive a physical assessment, blood and urine tests at each visit. In addition,
periodic assessments of dietary habits, body composition, oral glucose tolerance
testing, and health related quality of life questionnaires will be completed.
- A repeat MRI of the liver is performed at 48 weeks and at the end of the study to
evaluate any potential changes in liver fat and inflammation. In addition, there is a
follow-up liver biopsy at 48 weeks and an optional liver biopsy at 96 weeks.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)