Trial Information

Summary: WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.

Status: Completed

Protocol Number: ML18596

Sponsor: Hoffmann-La Roche; Trimeris Inc.

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon in HIV-1 infected, ARV treatment-experienced adults

Brief Summary: The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 58.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Crossover
• 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. Steady state C trough Time frame: Weekly 2. Signs and symptoms associated with Fuzeon injections Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: September 22, 2008 at 2:47:27 PM