Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
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ClinicalTrials.gov Identifier: NCT00333736 |
Recruitment Status
:
Completed
First Posted
: June 6, 2006
Last Update Posted
: June 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Device: Biojector | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 337 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2008 |

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Device: Biojector
- 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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have taken enfuvirtide for at least one month
Exclusion Criteria:
Patients with hemophilia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333736
Canada, Ontario | |
Maple Leaf Medical Clinic | |
Toronto, Ontario, Canada, M5B 1L6 |
Principal Investigator: | Mona Loutfy, MD, FRCP(C) | University of Toronto |
Responsible Party: | Canadian Immunodeficiency Research Collaborative |
ClinicalTrials.gov Identifier: | NCT00333736 History of Changes |
Other Study ID Numbers: |
Roche-B1.0 |
First Posted: | June 6, 2006 Key Record Dates |
Last Update Posted: | June 5, 2012 |
Last Verified: | June 2012 |
Keywords provided by Canadian Immunodeficiency Research Collaborative:
Injection site reactions enfuvirtide administration |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Enfuvirtide HIV Fusion Inhibitors Viral Fusion Protein Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |