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
Collaborator Hoffmann-La Roche
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model natural history
Time perspective longitudinal

Eligibility Criteria

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

Additional Information

Official title The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by Institute for Interdisciplinary Infectiology.