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

Primary Purpose

Human Immunodeficiency Virus

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Biojector

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Injection site reactions, enfuvirtide administration

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who have taken enfuvirtide for at least one month Exclusion Criteria: Patients with hemophilia

Sites / Locations

Maple Leaf Medical Clinic

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00333736

First Posted

June 2, 2006

Last Updated

June 4, 2012

Sponsor

Canadian Immunodeficiency Research Collaborative

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT00333736

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Canadian Immunodeficiency Research Collaborative

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

Injection site reactions, enfuvirtide administration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

337 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Biojector

Intervention Description

All patients received biojector to use with BID enfuvirtide doses

Primary Outcome Measure Information:

Title

To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have taken enfuvirtide for at least one month Exclusion Criteria: Patients with hemophilia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mona Loutfy, MD, FRCP(C)

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maple Leaf Medical Clinic

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1L6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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