A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy
Goal of Study
The National Institutes of Health is conducting a research study to evaluate HIV-positive patients, aged 18 and older (without hepatitis B or C co-infection), with chronically elevated hepatic transaminases while on HAART for evidence of fibrosis or other liver pathology by examining liver biopsy specimens. The study will include a screening visit, physical exam, laboratory tests, abdominal CT, and a liver biopsy procedure. A specialized ultrasound to look at liver stiffness may also be performed. There will be up to four visits prior to liver biopsy and four follow-up visits after biopsy.
We will obtain a liver biopsy (a sample of tissue) for examination. A liver biopsy is the only reliable way to assess how much damage there is to the liver. We will perform radiologic studies, including a CT scan. We will also collect blood. Volunteers will be compensated.
- You are age 18 or older, with documented HIV-infection.
- You are willing to have a liver biopsy.
- You have a primary care physician.
- You have been on antiretroviral therapy for HIV for at least 12 months, with no changes to medication regimen in the past 3 months.
- You have repeatedly had elevated transaminases (AST and/or ALT) for at least six months, documented on at least three separate occasions.
- You have a normal platelet count.
- You are not pregnant.
- You do not have active hepatitis A, B, or C.
- You are not allergic to lidocaine.