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
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office Toll Free: 1-800-411-1222 TTY: 1-866-411-1010 Se habla español. Office hours: 8 am to 8 pm, Eastern Time |
back to top