NIAID HIV and Emerging Infectious Diseases Program

TRANSAM Study

Study name

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

Study number

06-CC-0153

Goal of Study

The NIH 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 6 months, documented on at least 3 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

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