HIV Infections Clinical Trial
Official title:
Use of Single Photon Emission Computed Tomography (SPECT) as a Noninvasive Alternative to Liver Biopsies in Assessing Liver Involvement in Subjects Coinfected With HIV and Hepatitis C Virus (HCV)
The purpose of this study is to find if the Single Photon Emission Computed Tomography
(SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from
the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV).
A standard way to examine the liver for disease has been to perform a liver biopsy. The
SPECT scan, which takes a picture of the liver, has been found to be effective in
determining liver damage but studies need to be done in patients with hepatitis. This study
will compare the effectiveness of the liver biopsy and SPECT scan in determining liver
disease in patients with HIV and HCV. The SPECT scan might be a good replacement for the
liver biopsy if it is found to be as good as or better than liver biopsies.
Assessment with a liver biopsy is currently the standard of practice to determine the status
of liver involvement in patients with HCV. A direct comparison between SPECT results and
liver pathology has been examined in patients with liver disease other than infectious
hepatitis. SPECT has been found to be more accurate than standard liver-spleen scans in
assessing liver pathology. While current data suggest that liver pathology may correlate
with SPECT, which specific SPECT parameters are predictive of certain hepatic pathology is
unknown. The pilot study will compare SPECT parameters with the results of liver biopsies to
determine the limitations of SPECT.
All screened patients are registered into Step 1, in which they receive a radioactive tracer
injection and SPECT scan. Specific SPECT parameters will be measured to determine a grading
scale corresponding to that used in liver biopsy results. Some patients undergoing a second
liver biopsy in A5071 are enrolled into Step 2, with permission from protocol co-chairs, in
which a pregnancy test and second SPECT scan are performed. Patients are reimbursed for
completing each SPECT scan. SPECT scans or copies are reviewed to establish which parameters
correspond to category E of the Knodell stage based on severity of fibrosis.
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