Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Study to Assess Patient Satisfaction, Quality of Life and Adverse Events of Patients Using the Biojector Versus Standard Needles for Enfuvirtide Administration|
- To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.
|Study Start Date:||May 2005|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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.
|Maple Leaf Medical Clinic|
|Toronto, Ontario, Canada, M5B 1L6|
|Principal Investigator:||Mona Loutfy, MD, FRCP(C)||University of Toronto|