NCT00333736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

June 2, 2006

Last Update Submit

June 4, 2012

Conditions

Human Immunodeficiency Virus

Keywords

Injection site reactionsenfuvirtide administration

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

BiojectorDEVICE

All patients received biojector to use with BID enfuvirtide doses

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have taken enfuvirtide for at least one month

You may not qualify if:

  • Patients with hemophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maple Leaf Medical Clinic

Toronto, Ontario, M5B 1L6, Canada

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeInjection Site Reaction

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesExtravasation of Diagnostic and Therapeutic MaterialsPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Mona Loutfy, MD, FRCP(C)

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

May 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2008

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

CA(1)