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

Roche

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: enfuvirtide [Fuzeon]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337701

ML19849

Details and patient eligibility

About

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.

Enrollment: 326 patients

Sex: All

Ages: 16+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: enfuvirtide [Fuzeon]

Drug: enfuvirtide [Fuzeon]

2

Experimental group

Treatment:

Drug: enfuvirtide [Fuzeon]

Drug: enfuvirtide [Fuzeon]