Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-27 @ 2:50 AM
Study NCT ID:
NCT01056393
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2010-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigator-Sponsored Protocol - Continued Use of Ibalizumab
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': 'C481504', 'term': 'ibalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'dispFirstSubmitDate': '2018-04-11', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2010-01-22', 'dispFirstSubmitQcDate': '2018-04-11', 'studyFirstSubmitQcDate': '2010-01-25', 'dispFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Laboratory testing that includes routine HIV-1 viral load and CD4+ cell counts will be completed to assess the continued benefit of ibalizumab to the patient's HIV treatment.", 'timeFrame': 'Every two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.', 'detailedDescription': 'Ibalizumab is to be administered to HIV-infected patients that have responded (defined as a minimum 0.7 log10 decline in HIV-1 viral load from TMB-202 Baseline) on the TMB-202 protocol. In addition to the investigator-selected Optimized Background Regimen, patient(s) will continue to receive the TMB-202 randomized dose of ibalizumab in open-labeled fashion (800mg IV every two weeks or 2000mg IV every four weeks) as per their original drug assignment for the TMB-202 protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Capable of understanding and have voluntarily signed the ICF\n* Have documented HIV-1 infection\n* Have successfully completed Protocol TMB202 (Amendment 2)(Week 16)\n* Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure\n* Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason\n* Are able and willing to comply with all protocol requirements and procedures\n* Are 18 years of age or older\n* If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.\n\nExclusion Criteria:\n\n* Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV\n* Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study\n* Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations\n* Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation"}, 'identificationModule': {'nctId': 'NCT01056393', 'briefTitle': 'Investigator-Sponsored Protocol - Continued Use of Ibalizumab', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Investigator-Sponsored Protocol - Continued Use of Ibalizumab', 'orgStudyIdInfo': {'id': '5460'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ibalizumab 800mg Q2Weeks', 'description': 'Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen', 'interventionNames': ['Drug: ibalizumab 800mg Q2Weeks']}, {'type': 'EXPERIMENTAL', 'label': 'ibalizumab 2000mg Q4Weeks', 'description': 'Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen', 'interventionNames': ['Drug: ibalizumab 2000mg Q4Weeks']}], 'interventions': [{'name': 'ibalizumab 800mg Q2Weeks', 'type': 'DRUG', 'otherNames': ['TNX-355', 'TMB-355'], 'description': 'Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg every 2 weeks.', 'armGroupLabels': ['ibalizumab 800mg Q2Weeks']}, {'name': 'ibalizumab 2000mg Q4Weeks', 'type': 'DRUG', 'otherNames': ['TNX-355', 'TMB-355'], 'description': 'Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 2000mg every 4 weeks.', 'armGroupLabels': ['ibalizumab 2000mg Q4Weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'William Towner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'TaiMed Biologics Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Partner Physician', 'investigatorFullName': 'William J. Towner', 'investigatorAffiliation': 'Kaiser Permanente'}}}}