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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
  Purpose
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.

Condition Intervention Phase
Human Immunodeficiency Virus Device: Biojector Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Canadian Immunodeficiency Research Collaborative:

Primary Outcome Measures:
  • 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.


Enrollment: 337
Study Start Date: May 2005
Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Biojector
    All patients received biojector to use with BID enfuvirtide doses
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria:

Patients with hemophilia

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333736


Locations
Canada, Ontario
Maple Leaf Medical Clinic
Toronto, Ontario, Canada, M5B 1L6
Sponsors and Collaborators
Canadian Immunodeficiency Research Collaborative
Roche Pharma AG
Investigators
Principal Investigator: Mona Loutfy, MD, FRCP(C) University of Toronto
  More Information

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT00333736     History of Changes
Other Study ID Numbers: Roche-B1.0
First Submitted: June 2, 2006
First Posted: June 6, 2006
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Canadian Immunodeficiency Research Collaborative:
Injection site reactions
enfuvirtide administration

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents


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