Liver Fibrosis in HIV-Infected Patients With Elevated Liver Enzymes on Antiretroviral Therapy

Completed

Conditions studied: Liver Fibrosis, Steatohepatitis, Elevated Transaminases

In brief

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.

Key facts

Study ID

NCT00326482

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

127

Starts

2006-07-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Chronic hepatitis B infection (defined as positive HBsAg or hepatitis B viral load greater than 10,000 copies/ml).
• Hepatitis C infection (defined as positive HCV viral load) or history of treatment for chronic hepatitis C.
• Acute Hepatitis A infection (defined as HAV IgM positive).
• Suspected rhabdomyolysis (e.g., markedly elevated AST with elevated CPK).
• Known or suspected autoimmune hepatitis.
• Known or suspected biliary diseases, such as primary biliary cirrhosis or sclerosing cholangitis.
• Known or suspected Wilson's disease, alpha-1-antitrypsin deficiency, celiac disease.
• History of primary hemochromatosis, glycogen storage disease, amyloidosis, or cystic fibrosis.
• Clinical evidence of decompensated liver disease (e.g., jaundice, ascites, esophageal varices, or hepatic encephalopathy).
• Active clinical pancreatitis.
• Chronic renal disease.
• Morbid obesity (BMI greater than or equal to 40), if judged to be a contradiction to percutaneous liver biopsy
• AFP greater than or equal to 100 ng/mL.
• Hepatoma or hepatocellular carcinoma.
• Pregnancy.
• Active opportunistic infection (except oral thrush) or neoplasm (except Kaposi's sarcoma, skin cancer, or cancer of the cervix or anus, unless known or suspected liver metastasis).
• Severe psychiatric disorder that would interfere with adherence to protocol requirements. Individuals who have a stable psychiatric condition may be eligible.
• Decompensated cardiac or pulmonary disease limiting physical activity (e.g., New York Heart Association Heart Failure Class 2 or higher).
• History of unexplained bleeding.
• Allergy to lidocaine.
• Current use or a history of treatment with interleukin-2, interferon-alpha or other investigational agent(s) within 6 months of protocol screening. However, antiretroviral medication obtained through expanded access programs are permitted.
• Current use or a history of treatment with a systemic corticosteroid, immunosuppressive or cytotoxic agent within 90 days of protocol screening. However, volunteers receiving no more than one day of corticosteroid therapy in the 90 days prior to screening will be eligible.
• Any medical condition for which an investigator believes liver biopsy may be contraindicated.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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