Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

Updates regarding government operating status and resumption of normal operations can be found at


Study Name

A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy

Study Number


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.

Study Regimen

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.

Eligibility Criteria

  • 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.
Content last reviewed on October 26, 2011