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

Biojector 2000 Open-Label Safety Study (BOSS) to Evaluate Signs and Symptoms Associated With a Needle-free Injection Device for Administration of Fuzeon to Patients With HIV-1 Infection

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00337701

Enrollment

326

Registered

2006-06-16

Start date

2006-06-30

Completion date

2007-01-31

Last updated

2015-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needle and syringe. 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.

Interventions

DRUGenfuvirtide [Fuzeon]

90mg sc bid by Biojector 2000 NFID for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult patients \>=16 years of age; * current or former Fuzeon user who may benefit from needle-free administration of Fuzeon; * naive to use of the B2000 device; * positive test results for human immunodeficiency virus infection.

Exclusion criteria

* patients naive to Fuzeon; * inability to self-inject Fuzeon, or no reliable caregiver to administer injections; * evidence of active, untreated, opportunistic infections.

Design outcomes

Primary

Measure	Time frame
Composite endpoint (pain, induration, nodules/cysts)	Throughout study

Secondary

Measure	Time frame
AEs and ISRs	Throughout study

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026