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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
September 14, 2005
September 22, 2005
December 9, 2005
May 2003
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Complete list of historical versions of study NCT00216359 on ClinicalTrials.gov Archive Site
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Cohort Study for Patients Using Fuzeon (Enfuvirtide)
The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy

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.

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Observational
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
December 2006
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Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to understand or sign inform consent
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00216359
Radata Fuzeon Cohort
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Institute for Interdisciplinary Infectiology
Hoffmann-La Roche
Study Chair: Andreas Plettenberg, MD ifi-Institute for Interdisciplinary Infectiology
Institute for Interdisciplinary Infectiology
September 2005