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

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.

90mg sc bid by standard needle and syringe for 4 weeks, followed by 90mg sc bid by Biojector 2000 NFID for 4 weeks.

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.