Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-01 @ 3:22 PM
Study NCT ID:
NCT02569502
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who discontinue enfuvirtide due to adverse events\\n', 'timeFrame': 'Up to 102 weeks'}, {'measure': 'Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections', 'timeFrame': 'Up to 102 weeks'}, {'measure': 'Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events', 'timeFrame': 'Up to 102 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug', 'timeFrame': 'Up to 28 days after discontinuation of enfuvirtide'}, {'measure': 'Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR', 'timeFrame': 'Up to 102 weeks'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult or adolescent patients greater than (\\>)16 years of age\n* HIV-1 infection\n* CD4 count less than (\\<)350/cubic millimeters (mm\\^3)\n* HIV RNA viral load \\>10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)\n* Documented resistance, treatment-limiting toxicity, and/or \\>=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding;\n* Patients unable to self-inject;\n* Active, untreated opportunistic infection."}, 'identificationModule': {'nctId': 'NCT02569502', 'briefTitle': 'A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection', 'orgStudyIdInfo': {'id': 'ML18634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enfuvirtide', 'description': 'Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections', 'interventionNames': ['Drug: enfuvirtide']}], 'interventions': [{'name': 'enfuvirtide', 'type': 'DRUG', 'otherNames': ['Fuzeon'], 'description': 'Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.', 'armGroupLabels': ['Enfuvirtide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}