Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-01-08 @ 12:48 PM
Study NCT ID:
NCT00686205
Status:
COMPLETED
Last Update Posted:
2011-12-28
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}], '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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Peggy.Moreno@abbott.com', 'phone': '847-937-2044', 'title': 'Peggy Moreno', 'organization': 'Abbott Diagnostics Division'}, 'certainAgreement': {'otherDetails': "The PI must provide a copy of any proposed publication or presentation at least 30 days prior to submission for sponsor's review/approval. The PI must incorporate changes as the sponsor requires in order to protect the sponsor's proprietary rights and interests. The sponsor may require the PI to include acknowledgement of the sponsor's role in the study. The PI may be requested to delay publication/presentation an extra 60 days to enable sponsor to secure patent or other proprietary protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Subject related adverse events related to blood collection of the 19 follow-up specimens - 8/23/07 to 8/12/08.', 'description': 'Adverse event reporting was only applicable to the 19 donors that returned for follow-up specimen collection. Adverse event reporting does not apply to the donor specimens collected as part of the routine donation or for the specimens used for sensitivity provided by Abbott.\n\nThere were no device adverse events associated with testing.', 'eventGroups': [{'id': 'EG000', 'title': 'ABBOTT PRISM® HIV O Plus Assay Results for Specificity', 'description': 'Blood specimens collected from donors were tested by the investigational HIV test.', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity', 'description': 'Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PRISM HIV O Plus Test Data for Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15599', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Negative Donors', 'description': 'Donors with HIV-1/2 negative results using reference test and negative by HIV-1 RNA test'}], 'classes': [{'title': 'PRISM HIV O Plus reactive', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'PRISM HIV O Plus nonreactive', 'categories': [{'measurements': [{'value': '15589', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Specificity', 'ciPctValue': '95', 'paramValue': '99.94', 'ciLowerLimit': '99.88', 'ciUpperLimit': '99.97', 'statisticalMethod': 'Binomial Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Sample size is based on power of 80%, alpha level of 0.05, using the binomial distribution when comparing to a lower bound of specificity at 99.84.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per the protocol.'}, {'type': 'PRIMARY', 'title': 'PRISM HIV O Plus Test Data for Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1524', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV Positive Samples', 'description': 'Known HIV-1 or HIV-2 positive samples were used. Samples were determined to be positive by HIV-1 or HIV-2 western blot.'}], 'classes': [{'title': 'PRISM HIV O Plus reactive', 'categories': [{'measurements': [{'value': '1524', 'groupId': 'OG000'}]}]}, {'title': 'PRISM HIV O Plus nonreactive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Clinical Sensitivity', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.76', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Binomial Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '1,388 specimens from individuals positive for HIV antibodies and 136 specimens positive by supplemental testing from US individuals at increased risk of HIV infection or from an HIV-2 endemic area. These 1,524 specimens were used for the sensitivity calculation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABBOTT PRISM® HIV O Plus Assay Results for Specificity', 'description': 'Blood specimens collected from donors were tested by the investigational HIV test.'}, {'id': 'FG001', 'title': 'ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity', 'description': 'Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21606'}, {'groupId': 'FG001', 'numSubjects': '2505'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15599'}, {'groupId': 'FG001', 'numSubjects': '1524'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6007'}, {'groupId': 'FG001', 'numSubjects': '981'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Specimen handling procedure altered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5878'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Specimens not confirmed HIV positive', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '981'}]}]}], 'recruitmentDetails': '21606 donors enrolled from 6 geographically distinct blood donor and 1 plasmapheresis center. All donors were eligible if they signed a study consent form.\n\nIn addition, 1388 specimens positive for HIV antibodies and 1117 specimens from US individuals at increased risk of HIV infection or from an HIV-2 endemic area.', 'preAssignmentDetails': 'All subjects were assigned to one group. There was no pre-screening criteria specific for this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21606', 'groupId': 'BG000'}, {'value': '2505', 'groupId': 'BG001'}, {'value': '24111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABBOTT PRISM® HIV O Plus Assay Results for Specificity', 'description': 'Blood specimens collected from donors were tested by the investigational HIV test.'}, {'id': 'BG001', 'title': 'ABBOTT PRISM® HIV O Plus Assay Results for Sensitivity', 'description': 'Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>= 17 years', 'categories': [{'measurements': [{'value': '21606', 'groupId': 'BG000'}, {'value': '2454', 'groupId': 'BG001'}, {'value': '24060', 'groupId': 'BG002'}]}]}, {'title': 'not collected', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1683', 'groupId': 'BG001'}, {'value': '1683', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}]}, {'title': 'Not Collected', 'categories': [{'measurements': [{'value': '21606', 'groupId': 'BG000'}, {'value': '381', 'groupId': 'BG001'}, {'value': '21987', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21606', 'groupId': 'BG000'}, {'value': '1614', 'groupId': 'BG001'}, {'value': '23220', 'groupId': 'BG002'}]}]}, {'title': "Côte D'Ivoire", 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '840', 'groupId': 'BG001'}, {'value': '840', 'groupId': 'BG002'}]}]}, {'title': 'Cameroon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-16', 'studyFirstSubmitDate': '2008-05-21', 'resultsFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2011-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-04', 'studyFirstPostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRISM HIV O Plus Test Data for Specificity', 'timeFrame': '12 months', 'description': 'Negative HIV status was determined by the results of the HIV-1/HIV-2 comparator assay and HIV-1 qualitatitve RNA.'}, {'measure': 'PRISM HIV O Plus Test Data for Sensitivity', 'timeFrame': '12 months', 'description': 'Final HIV status was determined according to a supplemental testing algorithm for specimens positive by the investigational assay. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot and HIV-1 ribonucleic acid (RNA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy donors', 'HIV positives'], 'conditions': ['Healthy Donors', 'HIV Positive']}, 'descriptionModule': {'briefSummary': 'To test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (HIV) infection. Results will be compared to the current HIV screening assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy donors that have consented to study'}, 'identificationModule': {'nctId': 'NCT00686205', 'briefTitle': 'Evaluation of a Human Immunodeficiency Virus (HIV) Blood Screening Assay', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diagnostics Division'}, 'orgStudyIdInfo': {'id': '7B5-02-05R05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABBOTT PRISM HIV O Plus assay for Specificity', 'description': 'All subjects will have their blood tested by the investigational HIV test.', 'interventionNames': ['Device: collection of follow-up sample based on PRISM HIV O Plus result']}, {'type': 'NO_INTERVENTION', 'label': 'ABBOTT PRISM HIV O Plus Assay for Sensitivity', 'description': 'Samples collected from specimen vendors or from specimen collection studies were tested by the investigational HIV assay.'}], 'interventions': [{'name': 'collection of follow-up sample based on PRISM HIV O Plus result', 'type': 'DEVICE', 'description': 'Test blood samples with investigational HIV assay. If results are reactive, donors may be deferred and asked to return for a follow-up blood draw.', 'armGroupLabels': ['ABBOTT PRISM HIV O Plus assay for Specificity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52807', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mississippi Valley Regional Blood Center', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Community Blood Center of Greater Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '45402', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Community Blood Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '19123', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'American Red Cross', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38134', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Interstate Blood Bank, Inc.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78201', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Blood And Tissue Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Puget Sound Blood Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}