Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus
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)
2 other identifiers
observational
44
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJuly 30, 2008
June 1, 2003
December 6, 2000
July 29, 2008
Conditions
Keywords
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Community Health Network Inc
Rochester, New York, 14642, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bruce Shiramizu
- STUDY CHAIR
Dickens Theodore
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 6, 2000
First Posted
August 31, 2001
Last Updated
July 30, 2008
Record last verified: 2003-06