INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.

What Was Tested

This registered phase 2 trial tested Enfuvirtide.

The anticipated time on study tre atment is 3-12 months, and the target sample size is \<100 individuals.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 29 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: Adult patients, \>=18 years of age;. HIV-1 infection, with virologic failure;. On same stable HAART for \>4 weeks, with viral load \>1000 RNA copies/mL;.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: coinfection with hiv-2;; active opportunistic infection in 4 weeks prior to screening;; cirrhosis or severe liver failure;.

How the Study Was Run

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

The participants were allocated by chance, so the Enfuvirtide group and the comparison group should start out alike.

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

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.

It started in 2008-01 with completion listed for 2011-06.

It ran at 30 sites in France (30).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients with plasma viral load <50 copies/mL (time frame: Week 24).

It also tracked 1 secondary outcome, for example CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Enfuvirtide in 29 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.