NCT00333736

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

Prospective Study to Assess Patient Satisfaction, Quality of Life and Adverse Events of Patients Using the Biojector Versus Standard Needles for Enfuvirtide Administration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Canadian Immunodeficiency Research Collaborative · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DEVICE	Biojector	All patients received biojector to use with BID enfuvirtide doses

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-09-01
• Completion: 2008-09-01
• First posted: 2006-06-06
• Last updated: 2012-06-05

Locations

1 site across 1 country: Canada