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NIAID HIV and Emerging Infectious Diseases Program

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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 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

 

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Last Updated October 26, 2011