Status:
COMPLETED
Pioglitazone to Treat Fatty Liver in People With HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Hepatic Steatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can benefit HIV-infected people with fatty liver. Fatty changes of the liver (also known as steatosis) have be...
Detailed Description
While the introduction of antiretroviral therapy for HIV/AIDS has transformed HIV disease into a chronic infection for many, the use of antiretroviral therapy is also often associated with metabolic a...
Eligibility Criteria
Inclusion
- 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.
- Liver-to-spleen attenuation ratio less than 1 determined by CT and hepatic steatosis on liver biopsy within the past 1 year scored grade 1 or greater (i.e. greater than or equal to 5 percent of hepatocytes).
- Fasting glucose less than 126 mg/dL.
- Platelets greater than 50,000/microliters.
- Willingness to avoid medications and herbal supplements that may increase the risk of bleeding for one week prior to and one week following liver biopsy (e.g. aspirin, NSAIDs and ginko biloba).
- Willingness to restrict physical activity 72 hours after liver biopsy.
- Willingness to use 2 effective forms of contraception during the study to avoid pregnancy.
- Have a primary care physician.
- 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.
- MELD score greater than 9 or previously diagnosed cirrhosis.
- ALT greater than 3 times the upper limit of normal.
- Current or history of heart failure (NYHA Class III or IV cardiac status).
- Hemoglobin level less than 9g/dL.
- Active or ongoing infection with Hepatitis A, B, or C.
- Known or suspected liver disease such as autoimmune hepatitis, Wilson's disease, alpha-1-antitrypsin deficiency, cystic fibrosis, hemachromatosis, glycogen storage disease, amyloidosis, primary biliary cirrhosis, sclerosing cholangitis or any primary or secondary hepatic tumor.
- Current alcohol/substance abuse or mean alcohol consumption greater than 24g/day over past year.
- Use of growth hormone, prednisone or other anabolic agents (except for physiologic testosterone replacement) currently or within the past 6 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.
- Known history of insulin secreting tumor or symptomatic hypoglycemia.
- Current use or a history of treatment with interleukin-2, interferon-alpha, or other investigational agent(s) within the past 6 months. (This does not pertain to ARV's obtained through expanded access).
- Any medical condition for which the investigator believes a liver biopsy may be contraindicated.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00441272
Start Date
February 1 2007
Last Update
February 19 2010
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892