Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)

What Was Tested

The trial (phase 3) is built around Enfuvirtide.

It had two arms (groups): Intensification (experimental) and Standard (active comparator).

Lopinavir or efavirenz and emtricitabine/tenofovir and intensification with enfuvirtide (week 0 to 24).

Lopinavir or efavirenz and emtricitabine/tenofovir.

The registry classes the interventions as drug.

More on the Plan

This multicenter study will enroll 220 patients (n=110 in each arm).

The planned duration of the study is 48 weeks from the enrolment of the last subject.

The primary endpoint will be immunological success defined as CD4 cell count above 200 cells per mm3 after 24 weeks of initial treatment.

The durability of this response will be evaluated and patients will be followed for 48 weeks.

Who Took Part

195 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: CD4 cell count below 100 per mm3, or CD4 cell count below 200/mm3 and past history or presence of B or C(AIDS defining)event. Signed informed consent.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: pregnancy; breast feeding; coinfection with hiv-2 or infection with hiv-1 subtype o; neoplasia disease currently treated with chemotherapy or radiotherapy.

How the Study Was Run

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

Because people in this Enfuvirtide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2006-04 with completion listed for 2009-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Enfuvirtide in 195 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.