Trial Information

Summary: OPTIONS Study: A Study of Three Delivery Mechanisms for Fuzeon.

Status: No longer recruiting

Protocol Number: ML19233

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A study to evaluate the effect of three different delivery mechanisms for Fuzeon on injection site reactions.

Brief Summary: This study will determine whether different mechanisms of delivering Fuzeon have an impact on injection site reactions. HIV-infected adults currently receiving Fuzeon will be randomized to receive Fuzeon 90mg bid sc by a)27 gauge needle b)31 gauge needle or c)Bioject 2000 needle-free device for the first 12 weeks of the study. For weeks 12-24, patients may choose to remain on the randomized arm or may elect to receive one of the other delivery methods. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 60.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Crossover
• Endpoints: Safety/Efficacy

Study Type:

Condition: HIV Infections

Intervention Type: Drug

Intervention Name: enfuvirtide[Fuzeon]

Primary Outcome: 1. Injection site reactions (diameter, induration, erythema, swelling, pain, interference with normal activities, infection).

Key Secondary Outcomes: 1. Efficacy: CD4 cell count and HIV RNA viral load at weeks 0,12 and 24. Safety: SAEs. Quality of life: MOS-HIV 30.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2006

Trial Registration Date: 05/04/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:28:39 PM