T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

What Was Tested

In this phase 2 trial, researchers set out to test Enfuvirtide.

This study will evaluate T-20 in children.

The registry classes the interventions as drug.

More on the Plan

Children are stratified by age group (3 through 11 years and 12 through 16 years).

Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals.

Simultaneous to initiating T-20, all patients begin a "new" optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening.

Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48.

Who Took Part

Enrollment: 52 actual participants took part.

It was open to people of any sex aged from 3 years up to 16 years.

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

Examples of who could join: Are 3 through 16 years of age and have the consent of parent or guardian. Have a viral load of at least 5000 copies/ml. Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months. Have been on stable therapy for at least 4 weeks.

The full record lists 4 inclusion and 0 exclusion criteria.

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 2001-08 with completion listed for 2004-12.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343).

It also tracked 9 secondary outcomes, for example Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343), Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide, Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343), AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800), Number of Participants With Adverse Events (AEs) and Serious AEs and Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Enfuvirtide in 52 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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