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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Biojector

All patients received biojector to use with BID enfuvirtide doses

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Patients who have taken enfuvirtide for at least one month

Exclusion Criteria

Patients with hemophilia

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mona Loutfy, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Maple Leaf Medical Clinic

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Roche-B1.0

Identifier Type: -

Identifier Source: org_study_id

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