Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance

What Was Tested

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

The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.

It had 1 arm (groups): interruption of enfuvirtide (experimental).

Enfuvirtide interruption.

The registry classes the interventions as other.

More on the Plan

Some patients do not achieve an undetectable HIV viral load with an enfuvirtide (T20, Fuzeon) based antiretroviral regimen.

As a consequence, enfuvirtide resistant virus can emerge.

Subjects must have evidence of viral replication (HIV RNA \> 1,000 copies/ml on two consecutive measurements) while on a stable antiretroviral regimen containing enfuvirtide.

Patients will then interrupt enfuvirtide while continuing all other antiretroviral agents.

Who Took Part

The registry lists 25 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: Currently receiving continuous enfuvirtide-based antiretroviral therapy. Documentation of recent plasma HIV RNA level greater than the lower limit of detection (measured within the preceding 4 weeks). Screening plasma HIV-1 RNA level \> 1000 copies/mL. Negative serum pregnancy test (for women of childbearing potential) documented within the 14-day period prior to study entry. Subjects must be able to give written informed consent and agree to abide by the requirements of the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study; active hepatitis c infection requiring treatment with an interferon-based regimen.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Enfuvirtide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2000-05 with completion listed for 2005-11.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): CD4 (time frame: week 24).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Enfuvirtide in 25 people.

Its size is small, so on its own it can only give an early look.

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.