WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

What Was Tested

In this phase 4 trial, researchers set out to test Enfuvirtide.

The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon.

The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 58 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patients, \>=18 years of age with HIV-1 infection;. Previously treated with antiretroviral agents.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: prior use of fuzeon or t-1249;; inability to self-inject;; active, untreated opportunistic infection.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the Enfuvirtide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Enfuvirtide and the comparison in turn, acting as their own control.

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

It started in 2005-08 with completion listed for 2006-07.

It ran at 17 sites in United States (17).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Composite endpoint (pain, induration, nodules/cysts) (time frame: Throughout study).

It also tracked 2 secondary outcomes, for example Steady state C trough.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Enfuvirtide in 58 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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