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

NCT ID: NCT00006643

Last Updated: 2008-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Hepatitis C

Keywords

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Liver Hepatitis C Biopsy Tomography, Emission-Computed, Single-Photon

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Bruce Shiramizu

Role: STUDY_CHAIR

Dickens Theodore

Role: STUDY_CHAIR

Locations

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Stanford Univ Med Ctr

Stanford, California, United States

Site Status

Univ of Miami School of Medicine

Miami, Florida, United States

Site Status

Univ of Hawaii

Honolulu, Hawaii, United States

Site Status

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States

Site Status

Community Health Network Inc

Rochester, New York, United States

Site Status

Univ of Rochester Medical Center

Rochester, New York, United States

Site Status

Univ of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Univ of Cincinnati

Cincinnati, Ohio, United States

Site Status

Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Univ of Texas, Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Univ of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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AACTG A5096

Identifier Type: -

Identifier Source: secondary_id

ACTG A5096

Identifier Type: -

Identifier Source: org_study_id