Cohort Study for Patients Using Fuzeon (Enfuvirtide)

• Conditions: Antiretroviral Treatment; HIV Infections

• Registration Number: NCT00216359
• Lead Sponsor: Institute for Interdisciplinary Infectiology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Last Update Submitted: 2005-10-21
• Last Update Posted: 2005-10-25
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosis of HIV-Infection
• Planned to switch to a Fuzeon-containing antiretroviral therapy

Exclusion Criteria

• Inability to understand or sign inform consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Ifi-Institute for Interdisciplinary Infectiology; 🇩🇪 Hamburg, Germany