Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-01 @ 6:16 PM
Study NCT ID:
NCT00422695
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2007-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pain and Sensory Changes Assessment in HIV+ Patients
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': 'eliavel@sdm.rutgers.edu', 'phone': '973 972 7210', 'title': 'Eli Eliav', 'organization': 'Rutgers School of Dental Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed during the examination. The patients were patients of records and were routinely examined in the clinic.', 'description': 'No interventional procedures were made', 'eventGroups': [{'id': 'EG000', 'title': 'HIV +', 'description': 'Groups divided according to CD4 counts 105 HIV subjects', 'otherNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls', 'description': 'HIV -free subjects 38 Healthy Controls', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV +', 'description': 'Groups divided according to CD4 counts 105 HIV subjects'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'HIV -free subjects 38 Healthy Controls'}], 'classes': [{'title': 'Subjects with chronic Myogenic Pain', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with TMJ Disorder', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Subjects with Burning MouthSyndrome', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tests were performed during regular clinical visit. The test duration was about an hour', 'description': '1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.\n\nTo study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:\n\n* To detect the presence of sensory aberrations in the orofacial complex;\n* To identify which nerve types are involved;\n* To identify the type of orofacial pain based on both sensory testing and clinical findings.\n\n 3.To determine psychological condition and nutrition status in patients with HIV.\n\n 4.To find associations between inherited traits and development of neuropathic pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Comparisons of categorical variables were performed with Fischer's exact test. Trends in ordered categorical variables were tested with the chi square test."}, {'type': 'PRIMARY', 'title': 'Spontaneous Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV +', 'description': 'Groups divided according to CD4 counts 105 HIV subjects'}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'HIV -free subjects 38 Healthy Controls'}], 'classes': [{'title': 'Pain in Orofacial Region', 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Overall body pain', 'categories': [{'measurements': [{'value': '3.69', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'The time of the examination', 'description': 'Pain intensity as measured with Visual Analog Scale during the time of examination.\n\nThe subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain.', 'unitOfMeasure': 'units on a scale (0 to 10)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison was made between control and HIV+ subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV +', 'description': 'Groups divided according to CD4 counts 105 HIV subjects'}, {'id': 'FG001', 'title': 'Healthy Controls', 'description': 'HIV -free subjects 38 Healthy Controls'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV +', 'description': 'Groups divided according to CD4 counts'}, {'id': 'BG001', 'title': 'Healthy Controls', 'description': 'HIV -ve subjects'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.97', 'spread': '7.22', 'groupId': 'BG000'}, {'value': '42.53', 'spread': '12.57', 'groupId': 'BG001'}, {'value': '45.06', 'spread': '8.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2007-01-16', 'resultsFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2007-01-16', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-02', 'studyFirstPostDateStruct': {'date': '2007-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Chronic Myogenic Pain, TMJ Disoder, and Burning Mouth Syndrome', 'timeFrame': 'Tests were performed during regular clinical visit. The test duration was about an hour', 'description': '1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.\n\nTo study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:\n\n* To detect the presence of sensory aberrations in the orofacial complex;\n* To identify which nerve types are involved;\n* To identify the type of orofacial pain based on both sensory testing and clinical findings.\n\n 3.To determine psychological condition and nutrition status in patients with HIV.\n\n 4.To find associations between inherited traits and development of neuropathic pain.'}, {'measure': 'Spontaneous Pain Intensity', 'timeFrame': 'The time of the examination', 'description': 'Pain intensity as measured with Visual Analog Scale during the time of examination.\n\nThe subjects were required to report their perceived level of pain on a 10 cm VAS scale from zero to 10 with zero being no pain and 10 representing the worst pain imaginable. Given the ease of use of this method and its current use to measure pain, VAS scales were adapted to measure patient perceived orofacial pain wherein subjects were asked to draw a vertical line at the point on the horizontal line which best represented their pain response. Where left 0 is no pain and right -10 is maximal pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Quantitative Sensory Testing', 'Neuropathy', 'Treatment Experienced', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'There are about 42 million people in the world afflicted with HIV or AIDS with about 1 million patients in the US.\n\nThe epidemiology of orofacial pain has been reported extensively in the literature, yet the prevalence severity and level of pain affecting the head, face, neck and intraoral structures has not been explored in a population of HIV infected individuals.\n\nPain, in general terms, is a common experience in HIV infected patients, even in the absence of cancer or opportunistic infections. There is a variation in the prevalence of pain in these individuals depending on the stage of disease, care setting, and study methods. The purpose of this study is:\n\n1. To investigate the prevalence of orofacial pain in HIV infected patients during routine dental clinical assessment.\n2. To study the sensory phenotype of HIV+ patients and healthy volunteers using Quantitative Sensory Testing:\n\n * To detect the presence of sensory aberrations in the orofacial complex;\n * To identify which nerve types are involved;\n * To identify the type of orofacial pain based on both sensory testing and clinical findings.\n3. To determine psychological condition and nutrition status in patients with HIV.\n4. To find associations between inherited traits and development of neuropathic pain.', 'detailedDescription': 'Patients and control volunteers will be recruited from the Oral medicine Post-graduate clinic at NJDS. Medical history will be taken and will include age, gender, ethnicity, current and past illnesses, current and past medications, blood reports (CD4 and CD8 counts) which have been obtained during routine medical assessment. The clinician will perform a clinical head and neck examination. The examination shall include an extra-oral, cranial nerve and temporomandibular joint (TMJ) examination, and muscle palpation. A thorough intraoral examination will be performed. Patients will be examined for pathologies of the oral mucosa, teeth and periodontium prior to their participation in the study. The evaluation findings will be reported using the Research Diagnostic Criteria for Temperomandibular disorders. The patient will note level of pain on Visual Analogue Scale if there is any pre-existing orofacial pain. Psychological screening and nutritional questionnaires will be completed by the patient.\n\nQuantitative Sensory Testing will be conducted bilaterally on the face and intraorally on the tongue. Extraorally, the infraorbital and mental nerves regions will be tested bilaterally using thermal and electrical detection thresholds. Intraorally the tongue will be tested bilaterally for thermal and electrical detection threshold.\n\nMany of the differences among people in the way they respond to symptomatic therapies and their individual risk of HIV+ patients with neuropathic pain may be affected by their genetic makeup. We will search for these kinds of associations between inherited traits and development of neuropathic pain in this study.\n\nIf the patient presents with evidence for pathologies that requires extraction of any molar (based on clinical and radiographic findings), the patient will be assessed 3 days, 8 days post-extraction and then after 3 weeks for thermal and electrical detection thresholds.\n\nInclusion criteria:\n\nGroup I n = 40 HIV+ with CD4+T cells/mm³ \\> 500 as determined by previous routine medical examination and from previous blood reports.\n\nGroup II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical examination and from previous blood reports.\n\nGroup III n = 40 HIV+ with CD4+T cells/mm³ \\< 200 as determined by previous routine medical examination and from previous blood reports.\n\nControl Group n = 40 Healthy with normal blood reports, without dental pathologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV +ve subjects Healthy Controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup I n = 40 HIV+ with CD4+T cells/mm³ \\> 500 as determined by previous routine medical examination and from previous blood reports.\n\nGroup II n = 40 HIV+ with CD4+T cells/mm³ 200-499 as determined by previous routine medical examination and from previous blood reports.\n\nGroup III n = 40 HIV+ with CD4+T cells/mm³ \\< 200 as determined by previous routine medical examination and from previous blood reports.\n\nControl Group n = 40 Healthy with normal blood reports, without dental pathologies.\n\nExclusion Criteria:\n\n* Patients under 18 year of age.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT00422695', 'briefTitle': 'Pain and Sensory Changes Assessment in HIV+ Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Pain and Sensory Changes Assessment in HIV+ Patients, A Model for Pain and Sensory Changes Related Compromised Immune System.', 'orgStudyIdInfo': {'id': '0120060172'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV +', 'description': 'Groups divided according to CD4 counts'}, {'label': 'Healthy Controls', 'description': 'HIV -ve subjects'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07101', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Dental School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Eli Eliav, DMD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}