Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333736
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2006-06-02
Brief Title:
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
Sponsor:
Canadian Immunodeficiency Research Collaborative
Organization:
Canadian Immunodeficiency Research Collaborative
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None