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
Recruitment status was Active, not recruiting
Sponsor:
Institute for Interdisciplinary Infectiology
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
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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: | Additional Descriptors: Convenience Sample 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Enfuvirtide
U.S. FDA Resources
Further study details as provided by Institute for Interdisciplinary Infectiology:
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 June 18, 2013