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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT00333736
First received: June 2, 2006
Last updated: June 4, 2012
Last verified: June 2012

June 2, 2006
June 4, 2012
May 2005
September 2007   (final data collection date for primary outcome measure)
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.
To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.
Complete list of historical versions of study NCT00333736 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus
Device: Biojector
All patients received biojector to use with BID enfuvirtide doses
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
337
September 2008
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria:

Patients with hemophilia

Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00333736
Roche-B1.0
Yes
Canadian Immunodeficiency Research Collaborative
Canadian Immunodeficiency Research Collaborative
Roche Pharma AG
Principal Investigator: Mona Loutfy, MD, FRCP(C) University of Toronto
Canadian Immunodeficiency Research Collaborative
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP