DEVICE
Biojector
All patients received biojector to use with BID enfuvirtide doses
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
Status
Completed
Phase
Phase 2
Enrollment
337
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 6, 2006
Study start
May 2005
Primary completion
Sep 2007
Study completion
Sep 2008
Results posted
Not reported
Registry updated
Jun 5, 2012
Outcomes
What the study measures.
Primary outcomes
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
To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: Patients who have taken enfuvirtide for at least one month Exclusion Criteria: Patients with hemophilia
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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