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

September 14, 2005
October 21, 2005
May 2003
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00216359 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Natural History
Time Perspective: Longitudinal
Not Provided
Not Provided
Not Provided
Not Provided
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2006
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to understand or sign inform consent
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00216359
Radata Fuzeon Cohort
Not Provided
Not Provided
Institute for Interdisciplinary Infectiology
Hoffmann-La Roche
Study Chair: Andreas Plettenberg, MD ifi-Institute for Interdisciplinary Infectiology
Institute for Interdisciplinary Infectiology
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP