Cohort Study for Patients Using Fuzeon (Enfuvirtide)
This trial is active, not recruiting.
|Conditions||hiv infections, antiretroviral treatment|
|Treatments||fuzeon (enfuvirtide), laboratory diagnostic (cd4-cells), laboratory diagnostics (hiv-1 viral load), antiretroviral co-medication beside fuzeon|
|Sponsor||Institute for Interdisciplinary Infectiology|
|Start date||May 2003|
|End date||December 2006|
|Trial size||200 participants|
|Trial identifier||NCT00216359, Radata Fuzeon Cohort|
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.
|Observational model||natural history|
Male or female participants of any age.
Inclusion Criteria: - Diagnosis of HIV-Infection - Planned to switch to a Fuzeon-containing antiretroviral therapy Exclusion Criteria: - Inability to understand or sign inform consent
|Official title||The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy|
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