Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections

Stopped early · Phase 4 · Has a placebo group

Conditions studied: HIV, Hepatitis C, Liver Disease, Fatty Liver, Steatosis

In brief

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.

Key facts

Study ID

NCT00742326

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

13

Starts

2008-08-01

Expected to finish

2013-01-01

Last updated by the study team

2016-12-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Current thiazolidinedione use or use in the last 6 months, known allergy or sensitivity to a thiazolidinedione
• Use of insulin or other oral hypoglycemics, or known diabetes
• Current pregnancy, breast feeding, or pregnancy within the past 6 months or desire to become pregnant within the next 2 years.
• Child-Pugh-Turcotte (CPT) score greater than class A
• ALT greater than 4 times the upper limit of normal
• Current or history of heart failure (New York Heart Association [NYHA] Class III or IV cardiac status)
• Hemoglobin level less than 9g/dL
• Active or ongoing infection with Hepatitis A or B
• Known or suspected liver disease such as autoimmune hepatitis, Wilson's disease, alpha-1-antitrypsin deficiency, cystic fibrosis, hemochromatosis, glycogen storage disease, amyloidosis, primary biliary cirrhosis, sclerosing cholangitis, or any primary or secondary hepatic tumor
• Current alcohol/substance abuse
• Use of growth hormone, prednisone or other anabolic agents (except for physiologic testosterone replacement) currently or within the past 3 months. One day or less of corticosteroid within the prior 90 days of screening is allowed as is stable dose inhalation corticosteroids
• Concurrent use of ketoconazole
• Active opportunistic infection (except thrush) or neoplasm (except Kaposi's sarcoma, skin cancer, cancer of the cervix or anus)
• Any known contraindications to percutaneous liver biopsy including elevated PT/PTT
• Severe psychiatric illness that would interfere with adherence to protocol requirements
• Current treatment with interleukin-2, interferon-alpha, or other investigational agent(s) within the past 6 months (This does not pertain to ARVs obtained through expanded access)
• Any significant medical condition for which the investigator believes a liver biopsy or participation in the research protocol may be contraindicated
• Any contraindication to MRI scan, including excess body size

Where it is running

• VA Medical Center — Washington D.C., District of Columbia, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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