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Completed

NCT Number: NCT00333736

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

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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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Drug-Related Side Effects and Adverse Reactions Extravasation of Diagnostic and Therapeutic Materials Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Injection Site Reaction Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Maple Leaf Medical Clinic

Toronto, Ontario, M5B 1L6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have taken enfuvirtide for at least one month

Exclusion criteria

Patients with hemophilia

Treatment and study plan

Biojector

Device

All patients received biojector to use with BID enfuvirtide doses

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.

    Time frame: 1 month

    To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide.

Sponsors and collaborators

Lead sponsor

Canadian Immunodeficiency Research Collaborative

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Prospective Study to Assess Patient Satisfaction, Quality of Life and Adverse Events of Patients Using the Biojector Versus Standard Needles for Enfuvirtide Administration

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jun 6, 2006
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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