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| Tracking Information | |||||
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| First Received Date ICMJE | September 14, 2005 | ||||
| Last Updated Date | October 21, 2005 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00216359 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cohort Study for Patients Using Fuzeon (Enfuvirtide) | ||||
| Official Title ICMJE | The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy | ||||
| Brief Summary | The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new antiretroviral combination therapy (ART) are eligible to participate in this observation. Physicians may register patients online via the internet. They are offered to get an expert advice suggesting therapeutics for a new ART. Observation interval is every three month. However physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary. Total observation time for each patients is planned for two years. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal, Convenience Sample, Retrospective/Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00216359 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Radata Fuzeon Cohort | ||||
| Study Sponsor ICMJE | Institute for Interdisciplinary Infectiology | ||||
| Collaborators ICMJE | Hoffmann-La Roche | ||||
| Investigators ICMJE |
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| Information Provided By | Institute for Interdisciplinary Infectiology | ||||
| Verification Date | September 2005 | ||||
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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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