Lack of benefit of 3-month intensification with enfuvirtide plus optimized background regimen (OBR) versus OBR alone in patients with multiple therapeutic failures: the INNOVE study

What Was Tested

Researchers studied Enfuvirtide in this randomized controlled trial publication.

This was a prospective, randomized, open-label multicenter trial including patients infected with HIV-1 and harboring a multi-resistant virus that was still susceptible to at least 2 active compounds.

ENF was discontinued at Week 12.

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

Patients were randomized (1:1) to receive OBR + ENF or OBR alone.

Fifteen patients were randomized into the OBR group and 14 into the OBR + ENF group with a median viral load of 4.1 log(10) copies/ml and a median CD4+ cell count of 346 cells/mm(3) .

How the Study Was Run

In design terms this was a randomized, open-label and multicenter 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.

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

Running at several centres spread the Enfuvirtide study over different clinics and patient groups.

What Was Measured

The primary endpoint was the proportion of patients with plasma viral load <50 copies/ml at Week 24.

PubMed files the paper under topics including Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Enfuvirtide, HIV Envelope Protein gp41, HIV Infections, HIV-1 and Peptide Fragments.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Enfuvirtide.

The publication is from 2012 (Journal of medical virology), a journal based in United States.

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