Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial

What Was Tested

The paper reports a study of Enfuvirtide, published as a randomized controlled trial.

Who Took Part

The abstract describes 24, patients taking part.

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

One hundred and seventy patients with multidrug-resistant HIV infection and suppressed plasma HIV RNA levels < 400 copies/mL under an enfuvirtide-based regimen were randomized to maintain their regimen or to switch to a raltegravir-based regimen (immediate group) in a 48 week prospective, randomized, open-label trial.

At week 24, patients in the maintenance arm also switched to raltegravir (deferred group).

How the Study Was Run

In design terms this was a randomized, open-label and pilot study.

Random assignment meant chance, not the researchers, decided who got Enfuvirtide and who got the comparison, which limits bias.

Nothing was hidden in this open-label Enfuvirtide study: the patients and staff both knew the treatment.

It is described as a pilot, a small early test of whether a larger Enfuvirtide study would be practical.

Baseline genotypic susceptibility scores (GSSs) were calculated using available historical resistance tests.

The EASIER ANRS 138 trial is registered at ClinicalTrials.gov (NCT00454337).

What Was Measured

Topics PubMed links to this paper include Alanine Transaminase, CD4 Lymphocyte Count, Drug Resistance, Multiple, Viral, Endpoint Determination, Enfuvirtide, France and Genotype.

What This Means in Plain Language

The paper is a randomized, open-label and pilot study of Enfuvirtide in 24, patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2011 (The Journal of antimicrobial chemotherapy), a journal based in England.

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