Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
NCT00333736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 337
Last updated 2012-06-05
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.
Conditions
- Human Immunodeficiency Virus
Interventions
- DEVICE
-
Biojector
All patients received biojector to use with BID enfuvirtide doses
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY -
Canadian Immunodeficiency Research Collaborative
lead OTHER
Principal Investigators
-
Mona Loutfy, MD, FRCP(C) · University of Toronto
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-05-31
- Primary Completion
- 2007-09-30
- Completion
- 2008-09-30
Countries
- Canada
Study Locations
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