INCLUSION CRITERIA:
Men and women, 18 years of age or greater
Confirmed HIV infection by ELISA and Western blot
No changes in antiretroviral regimen within the prior 3 months--Individuals not currently taking antiretroviral therapy will be eligible. Individuals requiring medically indicated adjustments of antiretroviral therapy during the course of the study will be eligible.
Confirmed HCV infection, and no current or recent (within the past 3 months) HCV treatment and no plans to start HCV antiviral therapy in the foreseeable future.
H-MRS liver fat content greater than 5 percent and confirmed steatosis on liver biopsy within 1 year
Fasting glucose less than 126 mg/dL
Platelets greater than 50,000/uL
Willingness to avoid medications and herbal supplements which may increase the risk of bleeding for one week prior to and one week following liver biopsy (e.g. aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), and ginko biloba).
Willingness to restrict physical activity 72 hours after liver biopsy
If premenopausal female, willingness to use 2 forms of effective birth control on this study to avoid pregnancy.
Have a primary care physician
Willingness to have specimens stored.
EXCLUSION CRITERIA:
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
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009