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

Canadian Immunodeficiency Research Collaborative

Status and phase: Completed; Phase 2

Conditions: Human Immunodeficiency Virus

Treatments: Device: Biojector

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00333736

Roche-B1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 337 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients who have taken enfuvirtide for at least one month

Exclusion criteria

Patients with hemophilia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)