Cohort Study for Patients Using Fuzeon (Enfuvirtide)
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.
Drug: Fuzeon (Enfuvirtide)
Procedure: Laboratory diagnostic (CD4-cells)
Procedure: Laboratory diagnostics (HIV-1 viral load)
Drug: antiretroviral co-medication beside Fuzeon
|Study Design:||Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
|Official Title:||The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216359
|Ifi-Institute for Interdisciplinary Infectiology|
|Hamburg, Germany, D-20099|
|Study Chair:||Andreas Plettenberg, MD||ifi-Institute for Interdisciplinary Infectiology|