Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)

What Was Tested

This registered phase 2 trial tested Enfuvirtide.

Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain, provoked by the JC virus.

It usually occurs in subjects with impaired immune system as during HIV infection.

The registry classes the interventions as drug.

More on the Plan

An independent committee will meet regularly to estimate the validity of PML diagnosis in included patients.

These molecules will be chosen according to the past treatment of the patients.

A combination including efavirenz, lopinavir/ritonavir, and tenofovir/emtricitabine (under the shape of TRUVADA®) will be proposed to the naïve patients.

The projected duration of the period of inclusion will be 18 months.

Who Took Part

The registry lists 30 planned participants were the target.

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: 18 years of age and older. Have confirmed laboratory diagnosis of HIV infection. Presenting with a clinical history of active PML evolving (or continuing to deteriorate) for less than 90 days. Signed written inform consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: concomitant opportunistic infection of the central nervous system; pregnancy, breast-feeding; co-infection by the hiv2.

How the Study Was Run

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

Being open-label, the Enfuvirtide study did not mask who received what.

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

It started in 2005-04 with completion listed for 2007-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Estimation by the method of Kaplan-Meier of the rate of survival at M12.

It also tracked 4 secondary outcomes, for example Rate of survival and functional score (Modified Rankin Outcome Scale) at M12 and Evolution of the CD4 and CD8 T cells sub-populations and of the antivirus JC specific T cell responses at M12.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Enfuvirtide in 30 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.