Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection

What Was Tested

This randomized controlled trial paper looks at Enfuvirtide.

Injection site reactions (ISRs) can present a challenge to patients when using enfuvirtide (ENF).

Who Took Part

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

In this single-blind, crossover study, 58 ENF-naive participants were randomized to self-administer ENF with the NFID for 4 weeks (followed by 4 weeks using NS) or with the NS for 4 weeks (followed by 4 weeks using the NFID).

How the Study Was Run

The design is described as randomized, single-blind and crossover.

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

Only one side, usually the participants, was kept unaware of whether Enfuvirtide was given.

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

The methods mention a period of 4 weeks.

A primary composite endpoint of painful ISR was defined as the combination of grade 1-3 ongoing pain plus either associated grade 3-4 (> or =25 mm) induration or grade 2-4 nodules/cysts (>20 mm).

An ISR summary score described ISR frequency/severity.

Self-reported device preference was also evaluated at baseline and at study completion.

What Was Measured

Topics PubMed links to this paper include Enfuvirtide, Equipment Design, HIV Envelope Protein gp41, HIV Fusion Inhibitors, HIV Infections, Injections, Jet and Needles.

What This Means in Plain Language

The paper is a randomized, single-blind and crossover study of Enfuvirtide over 4 weeks.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2008 (Antiviral therapy), a journal based in England.

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