Genotypic changes in human immunodeficiency virus type 1 envelope glycoproteins on treatment with the fusion inhibitor enfuvirtide and their influence on changes in drug susceptibility in vitro

What Was Tested

The paper reports a study of Enfuvirtide, published as a clinical trial, phase iii.

Previous studies have established the importance of substitutions at amino acids 36-45 of HIV-1 gp41 in the development of viral resistance to the peptide fusion inhibitor enfuvirtide.

However, the influence of other loci in the HIV-1 envelope is not well established.

Who Took Part

The abstract describes 369 patients taking part.

The researchers examined full-length baseline and on treatment sequences of gp120 and gp41 for isolates from 369 patients in Phase III studies of enfuvirtide, including 281 patients receiving ENF+OB and 88 patients receiving OB alone.

Individual changes in gp41 and gp120 were evaluated for correlations with on treatment phenotype changes by analysis of variance (ANOVA).

How the Study Was Run

This modeling was done with (two-way) and without (one-way) ANOVA adjusting for the effects of any changes in gp41 amino acids 36-45 modeled as a single variable (ANY(36-45)).

What Was Measured

PubMed files the paper under topics including Amino Acid Sequence, Amino Acid Substitution, Drug Resistance, Viral, Enfuvirtide, Genotype, HIV Envelope Protein gp120 and HIV Envelope Protein gp41.

What This Means in Plain Language

This is a clinical trial, phase iii of Enfuvirtide in 369 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2006 (Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology), a journal based in Netherlands.

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