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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333736
First Posted: June 6, 2006
Last Update Posted: June 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
June 2, 2006
June 6, 2006
June 5, 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 ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Human Immunodeficiency Virus
Device: Biojector
All patients received biojector to use with BID enfuvirtide doses
Not Provided
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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

Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00333736
Roche-B1.0
Yes
Not Provided
Not Provided
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