Tesamorelin Effects on Liver Fat and Histology in HIV
Status:
Completed
Trial end date:
2019-07-24
Target enrollment:
Participant gender:
Summary
Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV)
infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of
patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of
NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and
fibrosis.
NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group
has previously shown that HIV-infected individuals with increased visceral adiposity
generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing
hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is
FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous
study, treatment with tesamorelin in HIV-infected individuals selected for abdominal
adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin
on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The
investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the
inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.
Phase:
N/A
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)