ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.

What Was Tested

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

The anticipated time on study treatment is 3-12 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

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: Adult patients, \>=18 years of age;. Documented chronic HIV infection;. Currently receiving a stable antiretroviral regimen;. CD4 cell count \<250 cells/mm3;. HIV RNA viral load \<400 copies/mL for \>12 months.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: prior exposure to fuzeon;; prior non-adherence to antiretroviral treatment regimens;; active opportunistic infection;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

The Enfuvirtide group and the comparison group ran side by side rather than switching.

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

It started in 2007-04 with completion listed for 2008-01.

It ran at 7 sites in Australia (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean change in CD4 cell count from baseline (time frame: Week 24).

It also tracked 3 secondary outcomes, for example Change in HIV RNA from baseline, Change in HIV RNA and CD4 cell count and Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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