Cohort Study for Patients Using Fuzeon (Enfuvirtide)

This study is ongoing, but not recruiting participants.

First Received: September 14, 2005 Last Updated: October 21, 2005 History of Changes

Sponsor:	Institute for Interdisciplinary Infectiology
Collaborator:	Hoffmann-La Roche
Information provided by:	Institute for Interdisciplinary Infectiology
ClinicalTrials.gov Identifier:	NCT00216359

Purpose

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.

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

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Official Title:	The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Institute for Interdisciplinary Infectiology:

Estimated Enrollment:	200
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2006

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Inability to understand or sign inform consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216359

Locations

Germany
Ifi-Institute for Interdisciplinary Infectiology
Hamburg, Germany, D-20099

Sponsors and Collaborators

Institute for Interdisciplinary Infectiology

Hoffmann-La Roche

Investigators

Study Chair:

Andreas Plettenberg, MD

ifi-Institute for Interdisciplinary Infectiology

More Information

Additional Information:

Radata-Homepage (German language) This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	Radata Fuzeon Cohort
Study First Received:	September 14, 2005
Last Updated:	October 21, 2005
ClinicalTrials.gov Identifier:	NCT00216359 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institute for Interdisciplinary Infectiology:

Treatment Experienced

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Enfuvirtide
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009