Effects of Growth Hormone Releasing Hormone in HIV

What Was Tested

In this not phased trial, researchers set out to test Tesamorelin.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 54 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Men and women age 18-65. Previously diagnosed HIV infection. Stable antiviral regimen for at least 12 weeks prior to enrollment. WC\>95 cm and WHR\>0.94 for male, WC\>94 cm and WHR\>0.88 for female occurring in the context of treatment for HIV disease. For female subjects 40yo or older, negative mammogram within one year of baseline.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: use of gh or ghrh within the past 6 months; change in lipid lowering or antihypertensive regimen within 3 months of screening; severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer.

How the Study Was Run

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

Because people in this Tesamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Tesamorelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2010-12 with completion listed for 2014-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Liver Fat (time frame: 6 months). Visceral Adipose Tissue (time frame: 6 months).

It also tracked 10 secondary outcomes, for example Intramyocellular Lipid, Endogenous Growth Hormone Secretion, Insulin Sensitivity, HbA1c, Insulin Like Growth Factor 1 (IGF-I) and Lipid Panel.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tesamorelin in 54 people.

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

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