Effects of Short-term Growth Hormone in HIV-infected Patients

What Was Tested

In this not phased trial, researchers set out to test GHRH (Growth Hormone-Releasing Hormone).

The researchers hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.

It had three arms (groups): one (experimental), one (experimental) and Growth Hormone Releasing Hormone (experimental).

The registry classes the interventions as drug.

More on the Plan

At baseline and after two weeks of treatment, the researchers will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp.

Subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Previously diagnosed HIV infection. Stable antiretroviral regimen for at least 12 weeks prior to enrollment. Waist circumference \>/= 95cm and waist-to-hip ratio \>/= 0.94 for males or waist circumference \>/=94cm and WHR \>/= 0.88 for females, occurring in the context of treatment for HIV disease.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: use of anti-diabetic agents, megace, testosterone, or any steroid use within 6 months of the study; use of gh or growth hormone releasing factor within six months of starting the study; change in lipid lowering or antihypertensive regimen within 3 months of screening.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the GHRH (Growth Hormone-Releasing Hormone) group and the comparison group should start out alike.

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

Being open-label, the GHRH (Growth Hormone-Releasing Hormone) study did not mask who received what.

It started in 2009-02 with completion listed for 2012-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug (time frame: after 2 weeks treatment).

It also tracked 1 secondary outcome, for example Insulin Sensitivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of GHRH (Growth Hormone-Releasing Hormone) in 25 people.

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

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

More context: the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.