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 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients With Chronically Elevated Transaminases on Antiretroviral Therapy|
- 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 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 evidence of hepatic inflammation by type and severity [ Time Frame: At study entry, potential for repeat liver biopsy staging during longitudinal follow-up ]
- Correlation between histopathologic findings on liver biopsy and clinical, laboratory and radiologic parameters [ Time Frame: At study entry, longitudinally ]
|Study Start Date:||May 12, 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326482
|Contact: Mary McLaughlin, R.N.||(301) firstname.lastname@example.org|
|Contact: Caryn G Morse, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Caryn G Morse, M.D.||National Institutes of Health Clinical Center (CC)|