Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT03407105
Status:
COMPLETED
Last Update Posted:
2018-01-23
First Post:
2018-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2006-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of treatment induced dose limiting toxicities (DLTs)', 'timeFrame': 'Up to 141 days'}, {'measure': 'Grade of treatment induced DLTs', 'timeFrame': 'Up to 141 days'}, {'measure': 'Number of treatment emergent AEs (adverse events)', 'timeFrame': 'Up to 141 days'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration observed post-dose (Cmax)', 'timeFrame': 'Up to 141 days'}, {'measure': 'Time of maximum plasma concentration observed post-dose (Tmax)', 'timeFrame': 'Up to 141 days'}, {'measure': 'HIV Ribonucleic Acid (RNA) level', 'timeFrame': 'Up to 141 days'}, {'measure': 'CD4 (cluster of differentiation) T (thymus) cell cytokine responses to Human Immunodeficiency Virus-1 (HIV-1) antigens', 'timeFrame': 'Up to 141 days'}, {'measure': 'CD4 T cell cytokine responses to Candida antigen', 'timeFrame': 'Up to 141 days'}, {'measure': 'CD4 T cell cytokine responses to tetanus antigen', 'timeFrame': 'Up to 141 days'}, {'measure': 'CD8 (cluster of differentiation) T cell cytokine responses to HIV-1 antigens', 'timeFrame': 'Up to 141 days'}, {'measure': 'CD8 T cell cytokine responses to Candida antigen', 'timeFrame': 'Up to 141 days'}, {'measure': 'CD8 T cell cytokine responses to tetanus antigen', 'timeFrame': 'Up to 141 days'}, {'measure': 'Lymphocyte Proliferation Assay (LPA) to HIV-1 antigens', 'timeFrame': 'Up to 141 days'}, {'measure': 'LPA to Candida antigens', 'timeFrame': 'Up to 141 days'}, {'measure': 'LPA to tetanus antigens', 'timeFrame': 'Up to 141 days'}, {'measure': 'Anti-tetanus toxin antibody level', 'timeFrame': 'Up to 141 days'}, {'measure': 'Number of CD4 T cells', 'timeFrame': 'Up to 141 days'}, {'measure': 'Number of CD8 T cells', 'timeFrame': 'Up to 141 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Immunodeficiency Virus (HIV)']}, 'referencesModule': {'references': [{'pmid': '29879143', 'type': 'DERIVED', 'citation': 'Colston E, Grasela D, Gardiner D, Bucy RP, Vakkalagadda B, Korman AJ, Lowy I. An open-label, multiple ascending dose study of the anti-CTLA-4 antibody ipilimumab in viremic HIV patients. PLoS One. 2018 Jun 7;13(6):e0198158. doi: 10.1371/journal.pone.0198158. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of 2 or 4 doses of MDX-010 in HIV-infected subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Detectable HIV viremia (HIV-1 RNA level between 1,000 and 100,000 copies/mL)\n* CD4 count greater than or equal to 100 cells/mm3\n* Current antiretroviral therapy regimen following at least 2 previous changes for documented virologic failure\n* Documented resistance tests demonstrating the presence of at least 1 mutation to each major therapeutic class of antiretroviral therapy\n* No significant organ compromise\n\nExclusion Criteria:\n\n* Initiation of any new medications that might reasonably affect the immune response or viral load within 4 weeks prior to screening\n* Tetanus booster immunization within 2 months of screening, or a history of anaphylaxis or severe local reaction to the tetanus vaccine\n* History of autoimmune disease at risk for recurrence\n* Current malignancy, except Stage A or B cervical carcinoma or basal cell carcinoma\n* Chronic viral hepatitis, due to Hepatitis B or Hepatitis C undergoing current treatment or Hepatitis B DNA greater than 25 pg/cc or Hepatitis C RNA greater than 20,000 IU/cc\n* Currently undergoing treatment or prophylaxis for tuberculosis infection\n* Chronic active infectious disease (other than HIV)'}, 'identificationModule': {'nctId': 'NCT03407105', 'briefTitle': 'A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase I, Open-Label, Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus', 'orgStudyIdInfo': {'id': 'MDX010-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Specified dose on specified days', 'interventionNames': ['Biological: MDX-010']}], 'interventions': [{'name': 'MDX-010', 'type': 'BIOLOGICAL', 'otherNames': ['Ipilimumab', 'BMS-734016'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower ID Medical Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Quest Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Care Resource', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Immunology Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Shannon Schrader, MD', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medarex', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}