Cohort Study for Patients Using Fuzeon (Enfuvirtide)

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. Identifier: NCT00216359
Recruitment Status : Unknown
Verified September 2005 by Institute for Interdisciplinary Infectiology.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : October 25, 2005
Hoffmann-La Roche
Information provided by:
Institute for Interdisciplinary Infectiology

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.

Condition or disease Intervention/treatment
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
Enrollment : 200 participants
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
Study Start Date : May 2003
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

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, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to understand or sign inform consent

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 identifier (NCT number): NCT00216359

Ifi-Institute for Interdisciplinary Infectiology
Hamburg, Germany, D-20099
Sponsors and Collaborators
Institute for Interdisciplinary Infectiology
Hoffmann-La Roche
Study Chair: Andreas Plettenberg, MD ifi-Institute for Interdisciplinary Infectiology

Additional Information: Identifier: NCT00216359     History of Changes
Other Study ID Numbers: Radata Fuzeon Cohort
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 25, 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
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents