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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333736
• Other study ID #: Roche-B1.0
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2006
• Last updated: June 4, 2012
• Start date: May 2005
• Est. completion date: September 2008

Study information

• Verified date: June 2012
• Source: Canadian Immunodeficiency Research Collaborative
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: September 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria:

Patients with hemophilia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Device:
• Biojector
All patients received biojector to use with BID enfuvirtide doses

Locations

Country	Name	City	State
Canada	Maple Leaf Medical Clinic	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Immunodeficiency Research Collaborative	Roche Pharma AG

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month	Yes