BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection

What Was Tested

In this phase 4 trial, researchers set out to test Enfuvirtide.

Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks.

The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 326 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

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

Examples of who could join: Adult patients \>=16 years of age;. Naive to use of the B2000 device;. Positive test results for human immunodeficiency virus infection.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: patients naive to fuzeon;; inability to self-inject fuzeon, or no reliable caregiver to administer injections;; evidence of active, untreated, opportunistic infections.

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 2006-06 with completion listed for 2007-01.

It ran at 44 sites in United States (42) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite endpoint (pain, induration, nodules/cysts) (time frame: Throughout study).

It also tracked 1 secondary outcome, for example AEs and ISRs.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Enfuvirtide in 326 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.