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NCT02196831 · ClinicalTrials.gov registry record · NA
Tesamorelin Effects on Liver Fat and Histology in HIV
A NA study of Human Immunodeficiency Virus (HIV) and Non-alcoholic Steatohepatitis (NASH), sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 61
- Enrollment target
- 2
- Study locations
NCT02196831: Completed NA study of Human Immunodeficiency Virus (HIV) and Non-alcoholic Steatohepatitis (NASH), sponsored by Massachusetts General Hospital.
NCT02196831 is a NA study of Human Immunodeficiency Virus (HIV) and Non-alcoholic Steatohepatitis (NASH) that has completed, run by Massachusetts General Hospital. The registered enrollment target is 61 participants, below the 505-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02196831, a NA study of Human Immunodeficiency Virus (HIV) and Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 61 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
change (value at 12 months minus value at baseline). Hepatic fat fraction is a standardized measure used to describe the percent fat in the liver. As it is determined by spectroscopy, it is quantified by the area under the lipid peak, standardized to the total area under the (lipid peak + water peak). Using 1-H Magnetic resonance spectroscopy to quantify liver fat in this manner was first described by Longo R et al., Invest Radiol, 1993, 28(4):297-302.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG tesamorelin
Study Locations (2)
Maryland
- National Institutes of Health - Bethesda
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-07-01 |
| Est. Completion | 2019-07-24 |
| Phase | NA |
What the finished NCT02196831 record still lists
NCT02196831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 505-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02196831 reports a single indexed study location in Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02196831 about?
NCT02196831 is a clinical study titled "Tesamorelin Effects on Liver Fat and Histology in HIV". 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 li...
What is the current status of trial NCT02196831?
This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2015-07-01. Estimated completion is 2019-07-24.
What conditions does trial NCT02196831 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV), Non-alcoholic Steatohepatitis (NASH), Non-Alcoholic Fatty Liver Disease (NAFLD).
What interventions are being tested in trial NCT02196831?
The interventions under investigation include: Placebo (DRUG), tesamorelin (DRUG).
Who is sponsoring clinical trial NCT02196831?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02196831 being conducted?
This trial has 2 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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