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Cohort Study for Patients Using Fuzeon (Enfuvirtide)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Institute for Interdisciplinary Infectiology.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00216359
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
Institute for Interdisciplinary Infectiology
  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: Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00216359     History of Changes
Other Study ID Numbers: Radata Fuzeon Cohort
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by Institute for Interdisciplinary Infectiology:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents