Metabolic Effects of Enfuvirtide in Healthy Volunteers

What Was Tested

In this phase 4 trial, researchers set out to test Enfuvirtide.

The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents.

A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.

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

The registry classes the interventions as drug.

Who Took Part

15 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy adult males. BMI between 19-24.9 kg/m2. Negative HIV, HBV and HCV serologies. Negative abuse drug urine test.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: prior psychiatric illness; prior dyslipemia; current smoker.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Enfuvirtide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Enfuvirtide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Enfuvirtide.

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

It started in 2005-09 with completion listed for 2006-03.

It ran at 1 site in Spain.

What Was Measured

Primary outcome: Change in fasting plasma total cholesterol (time frame: 6 weeks).

It also tracked 1 secondary outcome, for example Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Enfuvirtide in 15 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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