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

Inclusion Criteria

• •Age 18 years or older.
• •Ability to understand and willingness to provide written informed consent.
• •Willingness to undergo liver biopsy.
• •Willingness to comply with study requirements and procedures including storage of blood and liver tissue samples for use in future studies of HIV, AIDS, immune function, hepatic diseases, or other related diseases.
• •Established HIV diagnosis (documentation of HIV-1 infection by licensed ELISA testing and confirmed by Western Blot).
• •For the antiretroviral cohort on combination antiretroviral therapy for at least 12 months with stable regimen for at least 3 months prior to enrollment.
• •Chronically elevated transaminases for at least 6 months documented by an elevated AST and/or ALT on the following 3 occasions within the 12 months prior to enrollment:
• •1. Screening;
• •2. Less than 6 months (24 weeks) prior to enrollment (distinct from screening);
• •3. More than 6 months prior to enrollment.
• •Note: Occasions must be at least 8 weeks apart.
• •Specific screening lab criteria:
• •* AST and/or ALT greater than upper limit of normal;
• •* Absolute neutrophil count greater than 750/mm(3);
• •* PT/PTT within normal range;
• •* Platelets greater than 50,000/uL;
• •* Hemoglobin greater than or equal to 10 mg/dL;
• •* Creatinine less than or equal to 2.0 mg/dL;
• •* Negative serum or urine pregnancy test for females of childbearing potential.
• •Willingness to avoid medications that contain aspirin for 7 days PRIOR to liver biopsy and nonsteroidal anti-inflammatory drugs for 3 days PRIOR to liver biopsy.
• •Willingness to avoid medications that contain aspirin for a week AFTER liver biopsy.
• •Willingness to avoid other medications or herbal supplements (e.g., gingko biloba) which may increase the risk of bleeding before and after liver biopsy, as directed by the study team.
• •Willingness to restrict activity for 72 hours after liver biopsy.
• •Have a primary care physician.
• •HIV monoinfected individuals who have had a previous liver biopsy to evaluate chronically elevated transaminases on antiretroviral therapy or for another indication may be allowed to enroll in the study for the purposes of obtaining additional information on predictors of liver disease and to observe the natural history. In such instances, investigators will attempt to access this tissue for review.