Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration

Phase 2

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT00333736
• Lead Sponsor: Canadian Immunodeficiency Research Collaborative

Brief Summary

Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

Detailed Description

This study is a "N of one" trial where the patient is their own control. We will provide the quality of life questionnaire, the MOS-HIV questionnaire; ISR questionnaire and a satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide for at least one month. As well, demographics and laboratory data will be collected. The same procedures will be given 1 month after the use of Biojector in a follow-up visit.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-06
• Primary Completion: 2007-09
• Study Completion: 2008-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

Inclusion Criteria

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria

Patients with hemophilia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.	1 month	To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.

Trial Locations

Locations (1)

Maple Leaf Medical Clinic; 🇨🇦 Toronto, Ontario, Canada