NCT00216359

Cohort Study for Patients Using Fuzeon (Enfuvirtide)

The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (planned)
• Sponsor: Institute for Interdisciplinary Infectiology · Academic / Other
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Antiretroviral Treatment

Interventions

Type	Name	Description
DRUG	Fuzeon (Enfuvirtide)
PROCEDURE	Laboratory diagnostic (CD4-cells)
PROCEDURE	Laboratory diagnostics (HIV-1 viral load)
DRUG	antiretroviral co-medication beside Fuzeon

Timeline

• Start date: 2003-05-01
• Completion: 2006-12-01
• First posted: 2005-09-22
• Last updated: 2005-10-25

Locations

1 site across 1 country: Germany