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Tesamorelin Effects on Liver Fat and Histology in HIV | Clinical Trials | Clareo Health

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Tesamorelin Effects on Liver Fat and Histology in HIV

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

NCT02196831•Massachusetts General Hospital

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women 18-70yo
•HIV-infection and treatment with a stable antiretroviral regimen for ≥ 6 months
•Hepatic steatosis as demonstrated by liver fat fraction ≥5% on 1H-MRS
•Hepatitis C antibody negative, or, if Hepatitis C antibody positive, either: a) known clinical disease, successful therapy ≥1 year prior to baseline and undetectable HCV RNA, or b) HCV resolved spontaneously and undetectable HCV RNA. Hepatitis B surface antigen negative at screen visit
•For females ≥50yo, negative mammogram within 1 year of baseline visit
•If use of Vitamin E ≥400 IU daily (in any formulation), stable dose for ≥6 months prior to study.

Exclusion Criteria

•Heavy alcohol use defined as consumption of more than 20g daily for women or more than 30g daily for men for at least 3 consecutive months over the past 5 years
•Use of insulin or thiazoledinediones (TZDs), or HbA1c ≥7%. Individuals with mild diabetes that is well-controlled with diet and/or oral anti-diabetic agents besides TZDs will be included. Use of oral anti-diabetics must have been stable for ≥6 months prior to study entry.
•Known diabetic retinopathy.
•Known cirrhosis, or Child-Pugh score ≥7, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam.
•Chronic corticosteroid use except intermittent use of topical steroid creams and/or prior short-term physiologic corticosteroid use in the ≤ 6 months prior to baseline visit
•Chronic use of methotrexate, amiodarone, or tamoxifen
•Known diagnosis of Alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, or autoimmune hepatitis
•Use of GH or GHRH within the past 1 year
•Change in lipid lowering or anti-hypertensive regimen within 3 months of screening
•HgB \< 11.0 g/dL, CD4 \< 100 th/mm3, or HIV viral load \> 400 copies/mL
+11 more criteria

Locations (2)

National Institutes of Health

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

January 16, 2019

Completion Date

July 24, 2019

Last Updated

January 27, 2020

Enrollment

ACTUAL participants

Conditions

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

Interventions

tesamorelin

DRUG

Placebo

DRUG

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

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Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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RECRUITINGPHASE2

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

NCT04375800

Human Immunodeficiency Virus (HIV) Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Tesamorelin Effects on Liver Fat and Histology in HIV

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

Strategies to AchieVe Viral Suppression for Youth With HIV

Project neuroARTEMIS

Persuasive Health Communication Intervention for HIV/HCV