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

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ClinicalTrials.gov Identifier: NCT00333736
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : June 5, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Device: Biojector Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Device: Biojector
    All patients received biojector to use with BID enfuvirtide doses

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT00333736     History of Changes
Other Study ID Numbers: Roche-B1.0
First Posted: June 6, 2006    Key Record Dates
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