Tesamorelin Effects on Liver Fat and Histology in HIV

What Was Tested

In this not phased trial, researchers set out to test Tesamorelin for fatty liver & elevated liver enzymes.

It had two arms (groups): Tesamorelin (experimental) and Placebo (placebo comparator).

Placebo subcutaneously daily x 12 months double-blind phase. At the end of 12 months, subjects enter open-label tesamorelin treatment phase for 6 months.

The registry classes the interventions as drug.

Who Took Part

61 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Men and women 18-70yo. HIV-infection and treatment with a stable antiretroviral regimen for ≥ 6 months. For females ≥50yo, negative mammogram within 1 year of baseline visit.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Tesamorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Tesamorelin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-07-01 with completion listed for 2019-01-16.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy (time frame: change between baseline and 12 months).

It also tracked 3 secondary outcomes, for example Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score, Change in Alanine Aminotransferase (ALT) and Change in Aspartate Aminotransferase (AST).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tesamorelin in 61 people with fatty liver & elevated liver enzymes.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tesamorelin compound page, Fatty liver & elevated liver enzymes research.