Amdoxovir versus placebo with enfuvirtide plus optimized background therapy for HIV-1-infected subjects failing current therapy (AACTG A5118)

What Was Tested

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

Amdoxovir (2,6-diaminopurine dioxolane; DAPD) is a nucleoside reverse transcriptase inhibitor (NRTI) of human immunodeficiency virus-1 (HIV-1) with activity against wild-type and NRTI-resistant viruses.

Who Took Part

The abstract describes 18 subjects taking part.

PubMed indexes the participants as adults and middle-aged adults, both men and women.

The 18 subjects on study, nine in each arm, were unblinded and allowed to continue study treatment through 48 weeks.

How the Study Was Run

The design is described as randomized, placebo-controlled and pilot.

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.

Some subjects received a placebo instead of Enfuvirtide, giving a reference point.

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

The primary endpoints for comparison were time-averaged area under the curve minus baseline (AAUCMB) of plasma HIV-1 RNA concentration at 24 weeks and time to first serious (DAIDS toxicity table Grade > or = 3) adverse event (AE).

What Was Measured

PubMed files the paper under topics including CD4 Lymphocyte Count, Dioxolanes, Drug Resistance, Viral, Enfuvirtide, HIV Envelope Protein gp41, HIV Fusion Inhibitors and HIV Infections.

What This Means in Plain Language

The paper is a randomized, placebo-controlled and pilot study of Enfuvirtide in 18 subjects.

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.

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2006 (Antiviral therapy), a journal based in England.

More context: the Enfuvirtide compound page.