Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection

What Was Tested

In this phase 3 trial, researchers set out to test Enfuvirtide.

Participants will receive an initial 28 week induction treatment with enfuvirtide + OB.

After 28 weeks participants with a plasma viral load less than or equal to (\</=) 400 copies/milliliter (mL) at Week 16 and less than (\<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

It had three arms (groups): Enfuvirtide + OB (Not Randomized) (experimental), Enfuvirtide + OB (Randomized) (experimental) and OB alone (Randomized) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 84 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: Participants with HIV-1 infection. Female participants without any risk of pregnancy. Participants previously treated with drugs of 2 or 3 different antiretroviral classes. Cluster of differentiation 4 (CD4) cell count greater than (\>) 50 cells/cubic millimeter (mm\^3) at screening. Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: pregnant or breastfeeding women; presence of hiv-2 coinfection; participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial.

How the Study Was Run

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

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.

The Enfuvirtide group and the comparison group ran side by side rather than switching.

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

It started in 2004-12 with completion listed for 2008-03.

It ran at 71 sites in France (71).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52 (time frame: Week 52).

It also tracked 13 secondary outcomes, for example Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL), Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score, Change from baseline in viral load, Proviral deoxyribonucleic acid (DNA) level, Time to reappearance of viral load above 50 copies/mL in randomized participants and Changes from baseline in CD4 and CD8 cell counts.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Enfuvirtide in 84 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.