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:

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 26, 2016

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