Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT00636220
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2008-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jesfandiari@chembio.com', 'phone': '(631) 924-1135', 'title': 'Javan Esfandiari', 'phoneExt': '112', 'organization': 'Chembio Diagnostic Systems, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Confirmed HIV Infection', 'description': 'The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Confirmed HIV Infection', 'description': 'The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 to 3 days', 'description': 'Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.', 'unitOfMeasure': 'samples', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Effectiveness of MPC and Chembio Oral Fluid Collection Devices', 'timeFrame': '1-3', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Confirmed HIV Infection', 'description': 'The study population will consist of 100 participants with known (clinically or serologically) confirmed HIV infection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment time period was from March 13, 2008 to July 1, 2008. All enrollment was at the Evelyn Jordan Center, University of Maryland Baltimore (UMD).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Confirmed HIV Infection', 'description': 'participants with known (clinically or serologically) confirmed HIV infection.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fresh Oral Fluid Samples with known HIV reactivity', 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Fresh Oral Fluid samples were collected from participants with known HIV+ status. HIV reactivity was clinically or serologically confirmed.', 'unitOfMeasure': 'samples'}, {'title': 'Participants with known HIV reactivity', 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'participants with known HIV reactivity', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'oral fluid samples and venous blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2008-03-10', 'resultsFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-20', 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity', 'timeFrame': '1 to 3 days', 'description': 'Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.'}], 'secondaryOutcomes': [{'measure': 'The Effectiveness of MPC and Chembio Oral Fluid Collection Devices', 'timeFrame': '1-3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV-1 Infections'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral fluids.', 'detailedDescription': 'The objective of this study is to evaluate the feasibility of using fresh oral fluid specimens, from known HIV-positive individuals, to test for HIV-1 antibodies using both the DPP HIV 1/2 and HIV 1/2 STAT-PAK tests. Two oral fluid collection devices will be used and compared (MPC and Chembio collection devices) and the results obtained from oral fluids will be compared with those obtained from whole blood and plasma using paired samples from the same participants. The comparison between oral fluid, whole blood and plasma will be made in both Chembio devices (HIV 1/2 STAT-PAK and DPP HIV 1/2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of 100 participants with known (clinically or serologically) confirmed HIV infection. The participants, recruited by the staff of the Laboratory of Vial Diagnostics from the Evelyn Jordan Center, may be males or females (including pregnant women) at least 12 years of age from any ethnic and racial background.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with known HIV infection who are willing to participate in the study and who sign an informed consent (or assent), will be included in the study.\n* Patients on HAART treatment for HIV will be included, but this information as well as the dates (duration) of treatment will be obtained through the interview of study participants; a medical record review is not necessary or required. The study participant's responses will be recorded by study staff on a Data Collection Form.\n* Patients with immunosuppressive conditions other than HIV will be included if available, but will be limited to \\< 25% of the total test population. Immunosuppression will also be assessed through interview of study participants and/or through verbal confirmation by the treating physician; a medical record/chart review is not required.\n* Patients must be willing to undergo venipuncture to donate one tube of EDTA whole blood (not more than 10cc), and to provide three oral fluid samples.\n\nExclusion Criteria:\n\n* Patients who do not consent, withdraw consent, or for whom the investigator determines that venipuncture or gum swabbing may create a health risk will be excluded from the study.\n* Participants who have been enrolled in HIV vaccine studies will be excluded from the study. This will be ascertained through interview of study participants.\n* Participants who have been enrolled once in this study will be excluded from repeat enrollment.\n* Participants must not have introduced any substance into their oral cavity (gum, food, beverage, candy, lozenges, mouthwash, etc.) for 30 minutes prior to providing an oral fluid sample. This will be ascertained through interview of study participants."}, 'identificationModule': {'nctId': 'NCT00636220', 'acronym': 'HIVOF', 'briefTitle': 'Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chembio Diagnostic Systems, Inc.'}, 'officialTitle': 'Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids', 'orgStudyIdInfo': {'id': 'P-HIV-01'}, 'secondaryIdInfos': [{'id': 'UMB Protocol # H-29110'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A, Observational'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Evelyn Jordan Center, University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Niel Constantine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chembio Diagnostic Systems, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}