Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-27 @ 9:04 AM
Study NCT ID:
NCT00216359
Status:
UNKNOWN
Last Update Posted:
2005-10-25
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study for Patients Using Fuzeon (Enfuvirtide)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077560', 'term': 'Enfuvirtide'}], 'ancestors': [{'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015700', 'term': 'HIV Envelope Protein gp41'}, {'id': 'D014760', 'term': 'Viral Fusion Proteins'}, {'id': 'D050576', 'term': 'Membrane Fusion Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D015488', 'term': 'HIV Antigens'}, {'id': 'D000956', 'term': 'Antigens, Viral'}, {'id': 'D014764', 'term': 'Viral Proteins'}, {'id': 'D054299', 'term': 'env Gene Products, Human Immunodeficiency Virus'}, {'id': 'D015686', 'term': 'Gene Products, env'}, {'id': 'D012191', 'term': 'Retroviridae Proteins'}, {'id': 'D054298', 'term': 'Human Immunodeficiency Virus Proteins'}, {'id': 'D014759', 'term': 'Viral Envelope Proteins'}, {'id': 'D015678', 'term': 'Viral Structural Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'NATURAL_HISTORY'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2005-10-21', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2005-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections', 'Antiretroviral Treatment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.radata.de', 'label': 'Radata-Homepage (German language)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPhysicians may register patients online via the internet. They are offered to get an expert advice suggesting therapeutics for a new ART.\n\nObservation interval is every three month. However physicians are allowed to initiate new diagnostics, expert advice and therapeutic changes independently from these intervals if necessary.\n\nTotal observation time for each patients is planned for two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of HIV-Infection\n* Planned to switch to a Fuzeon-containing antiretroviral therapy\n\nExclusion Criteria:\n\n* Inability to understand or sign inform consent'}, 'identificationModule': {'nctId': 'NCT00216359', 'briefTitle': 'Cohort Study for Patients Using Fuzeon (Enfuvirtide)', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Interdisciplinary Infectiology'}, 'officialTitle': 'The Radata-Fuzeon Cohort - An Observational Cohort-Study in HIV-Infected Patients Using Fuzeon (Enfuvirtide) as Part of Their Antiretroviral Combination Therapy', 'orgStudyIdInfo': {'id': 'Radata Fuzeon Cohort'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fuzeon (Enfuvirtide)', 'type': 'DRUG'}, {'name': 'Laboratory diagnostic (CD4-cells)', 'type': 'PROCEDURE'}, {'name': 'Laboratory diagnostics (HIV-1 viral load)', 'type': 'PROCEDURE'}, {'name': 'antiretroviral co-medication beside Fuzeon', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Ifi-Institute for Interdisciplinary Infectiology', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Andreas Plettenberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'ifi-Institute for Interdisciplinary Infectiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Interdisciplinary Infectiology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}]}}}