Overview

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

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Hoffmann-La Roche
Collaborator:
Trimeris
Treatments:
Enfuvirtide