Assessment of drug-drug interaction potential of enfuvirtide in human immunodeficiency virus type 1-infected patients

What Was Tested

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

An open-label, 1-sequence crossover study was conducted in 12 HIV-1-infected adults, by use of a 5-drug cocktail consisting of caffeine, chlorzoxazone, dapsone, debrisoquin (INN, debrisoquine), and mephenytoin to assess the activities of CYP1A2, CYP2E1, CYP3A4, CYP2D6, and CYP2C19, respectively.

Dapsone was used to assess N-acetyltransferase activity.

Why It Was Studied

Enfuvirtide is the first drug to block human immunodeficiency virus type 1 (HIV-1) glycoprotein 41-mediated viral fusion to host cells.

This study investigated whether enfuvirtide can influence the activities of cytochrome P450 (CYP) enzymes in HIV-1-infected patients.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

Phenotypic index parameters were estimated and analyzed by ANOVA with factors subject and day (-15 and 6).

How the Study Was Run

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

Because people in this Enfuvirtide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Each person switched between Enfuvirtide and the comparison at some point, usually with a gap in between.

What Was Measured

The subject headings attached to it are Analysis of Variance, Confidence Intervals, Cytochrome P-450 Enzyme System, Drug Interactions, Enfuvirtide, HIV Envelope Protein gp41 and HIV Infections.

What This Means in Plain Language

The paper is a randomized, open-label and crossover study of Enfuvirtide.

Its findings take up roughly 4 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2004 (Clinical pharmacology and therapeutics), a journal based in United States.

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