Body Composition and Adipose Tissue in HIV

What Was Tested

This registered phase 4 trial tested Tesamorelin.

In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity.

This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy.

It had 1 arm (groups): Tesamorelin (experimental).

The registry classes the interventions as drug.

More on the Plan

Mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (CV) disease in patients with HIV disease.

VAT and hepatic lipid accumulation, are important health concerns for HIVLD patients.

Thus, a medication has been developed to augment GH secretion.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to people of any sex aged from 18 years up to 68 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: HIV-infected subjects with HIV lipodystrophy (HIVLD). Weight stable for 8 weeks prior to enrollment,. CD4 count \>100 cells/mm3. HIV RNA load \<1000 copies/mL. Stable combination anti-retroviral therapy (cART) of any regimen for ≥ 8 weeks prior to study enrollment.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: history of any malignancy; abnormal renal or liver function; pregnancy or women of childbearing age who are not using an acceptable means of contraception.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Tesamorelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-02-07 with completion listed for 2025-04-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hepatic Lipid Content (time frame: Baseline).

It also tracked 4 secondary outcomes, for example Visceral Adipose Tissue (VAT) Mass, Change in Relative Gene Expression of CD68 Gene, Change in Relative Gene Expression on TNF-alpha Gene and Change in Resting Energy Expenditure (REE).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Tesamorelin in 6 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Tesamorelin compound page, all human trials.