Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration
This study has been completed.
Sponsor:
Canadian Immunodeficiency Research Collaborative
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier:
NCT00333736
First received: June 2, 2006
Last updated: June 4, 2012
Last verified: June 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 2, 2006 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] 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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| Original Primary Outcome Measures ICMJE |
To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide. | ||||
| Change History | Complete list of historical versions of study NCT00333736 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration | ||||
| Official Title ICMJE | Prospective Study to Assess Patient Satisfaction, Quality of Life and Adverse Events of Patients Using the Biojector Versus Standard Needles for Enfuvirtide Administration | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Human Immunodeficiency Virus | ||||
| Intervention ICMJE | Device: Biojector
All patients received biojector to use with BID enfuvirtide doses |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 337 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients who have taken enfuvirtide for at least one month Exclusion Criteria: Patients with hemophilia |
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00333736 | ||||
| Other Study ID Numbers ICMJE | Roche-B1.0 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Canadian Immunodeficiency Research Collaborative | ||||
| Study Sponsor ICMJE | Canadian Immunodeficiency Research Collaborative | ||||
| Collaborators ICMJE | Roche Pharma AG | ||||
| Investigators ICMJE |
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| Information Provided By | Canadian Immunodeficiency Research Collaborative | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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