Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus

Completed

Conditions studied: HIV Infections, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00006643

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

44

Last updated by the study team

2008-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are enrolled in, or will soon enroll in, A5071. Patients may be eligible for the study if they are screening for A5071 and have a liver biopsy and SPECT scan but do not enter A5071. Patients who have stopped taking A5071 study drugs may also be eligible.
• Have had a liver biopsy, or will soon have a liver biopsy.
• Have a SPECT scan either before the liver biopsy or 2 weeks to 8 weeks after a liver biopsy.
• Intend to have the SPECT scan within 7 days of study entry.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Are allergic to chemicals in the radioactive tracer used for the SPECT scan.
• Are pregnant or breast-feeding.

Where it is running

• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Community Health Network Inc — Rochester, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Univ of Pennsylvania — Philadelphia, Pennsylvania, United States
• Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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