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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:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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 ] [ 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.


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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT00333736     History of Changes
Other Study ID Numbers: Roche-B1.0
Study First Received: June 2, 2006
Last Updated: June 4, 2012
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 16, 2013