Cohort Study for Patients Using Fuzeon (Enfuvirtide)
NCT00216359 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2005-10-25
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
- DRUG
-
Fuzeon (Enfuvirtide)
- PROCEDURE
-
Laboratory diagnostic (CD4-cells)
- PROCEDURE
-
Laboratory diagnostics (HIV-1 viral load)
- DRUG
-
antiretroviral co-medication beside Fuzeon
Sponsors & Collaborators
- collaborator INDUSTRY
-
Institute for Interdisciplinary Infectiology
lead OTHER
Principal Investigators
-
Andreas Plettenberg, MD · ifi-Institute for Interdisciplinary Infectiology
Eligibility
- Min Age
- 0 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-05-31
- Completion
- 2006-12-31
Countries
- Germany
Study Locations
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