Cohort Study for Patients Using Fuzeon (Enfuvirtide)
|ClinicalTrials.gov Identifier: NCT00216359|
Recruitment Status : Unknown
Verified September 2005 by Institute for Interdisciplinary Infectiology.
Recruitment status was: Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : October 25, 2005
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.
|Condition or disease||Intervention/treatment|
|HIV Infections Antiretroviral Treatment||Drug: Fuzeon (Enfuvirtide) Procedure: Laboratory diagnostic (CD4-cells) Procedure: Laboratory diagnostics (HIV-1 viral load) Drug: antiretroviral co-medication beside Fuzeon|
|Study Type :||Observational|
|Enrollment :||200 participants|
|Observational Model:||Natural History|
|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 Start Date :||May 2003|
|Study Completion Date :||December 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216359
|Ifi-Institute for Interdisciplinary Infectiology|
|Hamburg, Germany, D-20099|
|Study Chair:||Andreas Plettenberg, MD||ifi-Institute for Interdisciplinary Infectiology|