Cohort Study for Patients Using Fuzeon (Enfuvirtide)
Information source: Institute for Interdisciplinary Infectiology
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Antiretroviral Treatment
Intervention: Fuzeon (Enfuvirtide) (Drug); Laboratory diagnostic (CD4-cells) (Procedure); Laboratory diagnostics (HIV-1 viral load) (Procedure); antiretroviral co-medication beside Fuzeon (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Institute for Interdisciplinary Infectiology Official(s) and/or principal investigator(s):
Andreas Plettenberg, MD, Study Chair, Affiliation: ifi-Institute for Interdisciplinary Infectiology
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.
Clinical Details
Official title: The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy
Study design: Natural History, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of HIV-Infection
- Planned to switch to a Fuzeon-containing antiretroviral therapy
Exclusion Criteria:
- Inability to understand or sign inform consent
Locations and Contacts
Ifi-Institute for Interdisciplinary Infectiology, Hamburg D-20099, Germany
Additional Information
Radata-Homepage (German language)
Starting date: May 2003
Ending date: December 2006
Last updated: October 21, 2005
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