Effects of IGF-I in HIV Metabolic Disease

What Was Tested

The trial (phase 1) is built around Mecasermin (rhIGF-1).

This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.

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

Recombinant IGF-I.

The registry classes the interventions as drug.

More on the Plan

The main objectives of this study are the following: 1.

Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome. 2.

Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy. 3.

Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.

Who Took Part

16 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: HIV positive with undetectable viral load. No change in antiretrovirals for 3 months. Evidence of lipoatrophy in the limbs, and face or gluteal area. Dyslipidemia defined as:. Fasting triglycerides \> 200 OR.

The full record lists 9 inclusion and 16 exclusion criteria; among the exclusions: two consecutive viral \>75 or \> 50 copies/ml using the tests listed above; presence of aids wasting; coronary artery disease, cerebrovascular, or peripheral arterial disease.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Mecasermin (rhIGF-1) and who got the comparison, which limits bias.

The Mecasermin (rhIGF-1) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Mecasermin (rhIGF-1), so expectations could not easily colour the readings.

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

It started in 2011-06 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Body composition (time frame: 24 weeks).

It also tracked 1 secondary outcome, for example Glucose Homeostasis.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Mecasermin (rhIGF-1) in 16 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mecasermin (rhIGF-1) compound page, all human trials.