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

Status Completed

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.

Clinical Trial 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. ;

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

• NCT number: NCT00333736
• Study type: Interventional
• Source: Canadian Immunodeficiency Research Collaborative
• Status: Completed
• Phase: Phase 2
• Start date: May 2005
• Completion date: September 2008