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NCT00326482 · ClinicalTrials.gov registry record
Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
A clinical trial of Liver Fibrosis and Steatohepatitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 127
- Enrollment target
- 1
- Study location
NCT00326482 is a study of Liver Fibrosis and Steatohepatitis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 127 participants, below the 362-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00326482, a study of Liver Fibrosis and Steatohepatitis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will provide a basis for research on the impact of liver injury caused by antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT are common in HIV-infected patients taking antiretroviral medications and can indicate liver damage. Although there are a number of possible causes for these elevations, such as infections with a hepatitis virus, antiretroviral medications alone can lead to the elevations. The study will focus particularly on evidence of liver fibrosis, which is a sign of progressive liver damage. HIV-infected patients 18 and older who 1) have been taking combination antiretroviral therapy for at least 12 months and have been on a stable regimen for at least 3 months, and 2) have had elevated AST or ALT levels for at least 6 months may be eligible for this study. Patients who have had liver biopsies performed in the past may be eligible for participation. Participants undergo the following tests and procedures over a 12-month period: * Oral glucose tolerance test: The patient drinks a glucose (sugar) drink. Blood samples are then drawn over 2 hours through an intravenous (IV) line in the patient's arm. This test measures how high the patient's blood sugar and insulin levels rise after drinking a standard glucose load. * Transient elastography: This ultrasound test uses vibration (sound waves) to measure liver stiffness (fibrosis). Vibrations move faster through a fibrotic liver. * Triple-phase CT scan and single slice CT scan of L4-5: Patients fast for 4 hours before the CT scan. A contrast material is injected through a catheter placed in an arm vein to improve the visibility of the liver in the specialized X-ray images obtained in the CT scanner. * Liver biopsy: This test removes a small sample of liver tissue for microscopic examination, particularly for evidence of fibrosis. The skin over the biopsy site is numbed and a needle is passed through the skin and rapidly in and out of the liver. Patients may
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2006-07-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00326482
The ClinicalTrials.gov registry entry for NCT00326482 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 362-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (65% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Liver Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT00326482 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00326482 about?
NCT00326482 is a clinical study titled "Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy". This study will provide a basis for research on the impact of liver injury caused by antiretroviral therapy in HIV-infected patients. Elevated liver enzymes called AST and ALT are common in HIV-infected patients taking antiretroviral medications and can indicate liver damage. Although there are a nu...
What is the current status of trial NCT00326482?
This trial is currently completed. The enrollment target is 127 participants. The study started on 2006-07-31.
What conditions does trial NCT00326482 study?
This clinical trial studies the following conditions: Liver Fibrosis, Steatohepatitis, Elevated Transaminases.
Who is sponsoring clinical trial NCT00326482?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00326482 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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