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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 Nonalcoholic Steatohepatitis (NASH), sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
61
Enrollment target
2
Study locations

NCT02196831 is a NA study of Human Immunodeficiency Virus (HIV) and Nonalcoholic 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.

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The verdict

NCT02196831, a NA study of Human Immunodeficiency Virus (HIV) and Nonalcoholic 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.

Conditions Studied

Human Immunodeficiency Virus (HIV) Nonalcoholic Steatohepatitis (NASH) Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

  • DRUG Placebo
  • DRUG tesamorelin

Study Locations (2)

Maryland

  • National Institutes of Health - Bethesda

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2015-07-01
Est. Completion 2019-07-24
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02196831

The ClinicalTrials.gov registry entry for NCT02196831 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 505-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (88% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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), Nonalcoholic Steatohepatitis (NASH), Nonalcoholic 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.