CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
tesamorelin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02196831
NCT02196831N/ACompleted

Tesamorelin Effects on Liver Fat and Histology in HIV: A Collaborative UO1 Grant

Massachusetts General Hospital·interventional·Posted Jul 22, 2014·Updated Jan 27, 2020

In Brief

A clinical study evaluating tesamorelin and Placebo for Human Immunodeficiency Virus (HIV) and 2 related conditions. Completed, enrolled 61 participants across 2 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 22, 2014
Enrollment StartJul 1, 2015
Primary CompletionJan 16, 2019
Study CompletionJul 24, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.9 years ago

Interventions

tesamorelindrug

Placebodrug

inactive substance that looks like tesamorelin