Cohort Study for Patients Using Fuzeon (Enfuvirtide) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

October 21, 2005

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00216359 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cohort Study for Patients Using Fuzeon (Enfuvirtide)

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal, Convenience Sample, Retrospective/Prospective Study

Condition ^ICMJE

HIV Infections
Antiretroviral Treatment

Intervention ^ICMJE

Drug: Fuzeon (Enfuvirtide)
Procedure: Laboratory diagnostic (CD4-cells)
Procedure: Laboratory diagnostics (HIV-1 viral load)
Drug: antiretroviral co-medication beside Fuzeon

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

200

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Inability to understand or sign inform consent

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00216359

Responsible Party

Study ID Numbers ^ICMJE

Radata Fuzeon Cohort

Study Sponsor ^ICMJE

Institute for Interdisciplinary Infectiology

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Study Chair:

Andreas Plettenberg, MD

ifi-Institute for Interdisciplinary Infectiology

Information Provided By

Institute for Interdisciplinary Infectiology

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP