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NCT00216359 Clinical Trial

Cohort Study for Patients Using Fuzeon (Enfuvirtide)

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00216359
Other study ID # Radata Fuzeon Cohort
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 14, 2005
Last updated October 21, 2005
Start date May 2003
Est. completion date December 2006

Study information
Verified date September 2005
Source Institute for Interdisciplinary Infectiology
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Drug:
• Fuzeon (Enfuvirtide)

Procedure:
• Laboratory diagnostic (CD4-cells)

• Laboratory diagnostics (HIV-1 viral load)

Drug:
• antiretroviral co-medication beside Fuzeon

Locations
Country Name City State
Germany Ifi-Institute for Interdisciplinary Infectiology Hamburg

Sponsors (2)
Lead Sponsor Collaborator
Institute for Interdisciplinary Infectiology Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

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