Trial Information

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

Status: Completed

Protocol Number: ML19849

Sponsor: Hoffmann-La Roche; Trimeris Inc.

Company Division: Pharmaceutical

Official Scientific Title: 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

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. Target sample size is 300.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety

Study Type:

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide [Fuzeon]

Primary Outcome: 1. Composite endpoint (pain, induration, nodules/cysts) Time frame: Throughout study

Key Secondary Outcomes: 1. AEs and ISRs Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 16 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/16/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:36:19 PM