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

NCT00333736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2012-06-05

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus

Interventions

DEVICE

Biojector

All patients received biojector to use with BID enfuvirtide doses

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY
  • Canadian Immunodeficiency Research Collaborative

    lead OTHER

Principal Investigators

  • Mona Loutfy, MD, FRCP(C) · University of Toronto

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-09-30
Completion
2008-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00333736 on ClinicalTrials.gov