Cohort Study for Patients Using Fuzeon (Enfuvirtide)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Institute for Interdisciplinary Infectiology.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Institute for Interdisciplinary Infectiology
ClinicalTrials.gov Identifier:
NCT00216359
First received: September 14, 2005
Last updated: October 21, 2005
Last verified: September 2005
  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
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

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:
No publications provided

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

Keywords provided by Institute for Interdisciplinary Infectiology:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014