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HIV and Emerging Infectious Diseases Program

Non-Viral Liver Studies

The National Institutes of Health (NIH) houses the nation’s most renowned biomedical research institutions. The following clinical research studies are being conducted by NIAID and the NIH Clinical Center in Bethesda, Maryland:

A Pilot Study of Hepatic Fibrosis in HIV/AIDS Patients with Chronically Elevated Transaminases on Antiretroviral Therapy

(TRANSAM – Actively Recruiting)

NIH is conducting a research study to evaluate HIV-positive patients age 18 and older (without HBV or HCV co-infection) who have chronically elevated hepatic transaminases while on HAART, for evidence of fibrosis or other liver pathology, by examining liver biopsy specimens. The study will include a screening visit, a physical exam, laboratory tests, an abdominal CT, and a liver biopsy procedure. A specialized ultrasound to look at liver stiffness may also be performed. There will be up to four visits before liver biopsy and four follow-up visits after biopsy. Financial compensation will be provided for visits completed.

Tesamorelin Effects on Liver Fat and Histology in HIV

(TESLA – Protocol #15-I-0036)

Tesamorelin Effects on Liver Fat and Histology in HIV. The study is for people with HIV and are known or suspected to have non-alcoholic fatty liver disease, or NAFLD. NAFLD is a common health problem in people with HIV. It is a type of liver disease in which there is a build-up of fat in the liver, leading to liver inflammation. This damages the liver and can lead to liver cancer or liver failure. In addition to liver damage, NAFLD has been associated with increased belly fat and may raise the risk for heart disease and diabetes.

Currently, no drugs are specifically approved to decrease liver fat in HIV-infected patients with NAFLD. Other research studies suggest that a drug called tesamorelin (Egrifta) reduces liver fat in people with HIV. Tesamorelin has been approved by the Food and Drug Administration to decrease belly fat in HIV-infected people with an abnormal distribution of fat tissue. It works by stimulating the body to release a hormone that causes the breakdown of excess fat. The main purpose of this research study is to test if tesamorelin will reduce liver fat in HIV-infected patients with NAFLD. We also want to see if tesamorelin will reduce liver inflammation and signs of liver damage. In addition, we want to study how tesamorelin works in this population. Volunteers will be compensated.

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Last Updated May 21, 2015