Status:
TERMINATED
Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Hepatitis C
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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...
Detailed Description
Following the introduction of effective antiretroviral therapy for HIV, the management of co-morbidities such as hepatitis C virus (HCV) has taken on increasing significance in the care and health mai...
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. 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 or equal to 75,000/uL; INR less than 1.6
- 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), Vitamin E, fish oil and gingko 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00742326
Start Date
August 1 2008
End Date
January 1 2013
Last Update
December 9 2016
Active Locations (2)
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1
VA Medical Center
Washington D.C., District of Columbia, United States, 20422
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892