Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00326482|
Recruitment Status : Active, not recruiting
First Posted : May 17, 2006
Last Update Posted : June 30, 2020
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 be given a sedative for the procedure.
- Follow-up visits. Patients return for follow-up visits 1 to 4 weeks after the liver biopsy and three more times over the course of the study for a medical history, physical examination and blood tests.
Patients may participate in an additional 4-year follow-up, during which they have visits every 3-12 months and are offered the opportunity to repeat the biopsy no sooner than 1 year after the first biopsy.
|Condition or disease|
|Liver Fibrosis Steatohepatitis Elevated Transaminases|
|Study Type :||Observational|
|Actual Enrollment :||127 participants|
|Official Title:||A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients With Chronically Elevated Transaminases on Antiretroviral Therapy|
|Actual Study Start Date :||July 31, 2006|
Prior Liver Biopsy
HIV+ historical liver biopsy history
Prospective Liver Biopsy with ARV
HIV+ taking c/ARV medications
Prospective Liver Biopsy without ARV
HIV+ not taking c/ARV medications
- Presence of hepatic fibrosis on liver biopsy as measured histologically by stage [ Time Frame: At study entry, potential for repeat liver biopsy staging during longitudinal follow-up ]Liver Biopsy Scoring
- Liver biopsy evidence of hepatic steatosis as measured by degree (0 to 4), character and location [ Time Frame: At study entry, potential for repeat liver biopsy staging during longitudinal follow-up ]Liver Biopsy Scoring
- Liver biopsy evidence of hepatic inflammation by type and severity [ Time Frame: At study entry, potential for repeat liver biopsy staging during longitudinal follow-up ]Liver Biopsy Scoring
- Correlation between histopathologic findings on liver biopsy and clinical, laboratory and radiologic parameters [ Time Frame: At study entry, longitudinally ]Liver Biopsy Scoring
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326482
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Janaki C Kuruppu, M.D.||National Institutes of Health Clinical Center (CC)|