Study Name
Tesamorelin Effects on Liver Fat and Histology in HIV
Study Number
15-I-0036
Goal of Study
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 (FDA) 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.
Study Regimen
The FDA has given us permission to test this drug experimentally in this study. We plan to test tesamorelin in 60 HIV-infected people with NAFLD. Total participation time is 18 months. There are approximately 12 visits to the NIH. The first 12 months are blinded and placebo controlled, with half receiving tesamorelin and half receiving placebo. For the final six months, all participants will receive tesamorelin. The study includes physical exam, blood draws, DEXA scan, food diaries, activity diaries, liver ultrasound, and glucose tolerance testing. The study will also include a liver biopsy if the participant has not had one in the previous six months. As part of the study, you will give yourself an injection every day. Volunteers will be compensated.
Eligibility Criteria
- You are between 18 and 70 years old and have confirmed HIV infection.
- You have been on HIV medications for at least three months, with no changes in the regimen.
- You have, or are suspected of having, NAFLD.
- You do not have cirrhosis (end stage liver disease).
- You are willing to undergo study procedures including MRI, DEXA scan, liver ultrasound and liver biopsy, among others.
- You are willing to inject yourself daily with study drug/placebo for 18 months.
- You do not have active or ongoing infection with Hepatitis A, B, or C.
- You do not take insulin.
- You do not drink alcohol excessively.
- You have a primary care physician.