Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 6:47 PM
Study NCT ID:
NCT01107834
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2010-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heart Function in HIV-Negative Children Exposed to HIV and HAART
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': 'tcade@wustl.edu', 'phone': '314-286-1432', 'title': 'William T. Cade', 'organization': 'Washington University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women\n\nNo adverse events', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero\n\nNo adverse events', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Left Ventricular Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'OG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '12', 'groupId': 'OG000'}, {'value': '60', 'spread': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T-test to detect differences between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'left ventricular mass index measured by 2D echocardiography', 'unitOfMeasure': 'g/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fractional Shortening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'OG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '5', 'groupId': 'OG000'}, {'value': '37', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T-test to detect differences between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Fractional shortening measured by M-mode cardiography', 'unitOfMeasure': 'percentage of full contraction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Strain Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'OG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-21.1', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T-test to detect differences between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography', 'unitOfMeasure': 'percentage of full deformation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Systolic Myocardial Velocity During Systole (S')", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'OG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T-test to detect differences between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Systolic myocardial velocity during systole measured by tissue Doppler echocardiography', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Early to Late Diastolic Filling Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'OG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T-test to detect differences between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Early to late diastolic filling ratio measured by tissue Doppler echocardiography', 'unitOfMeasure': 'ratio, unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Wall Velocity During Early Diastole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'OG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T-test to detect differences between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging', 'unitOfMeasure': 'cm/s', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'FG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'id': 'BG001', 'title': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '2', 'groupId': 'BG000'}, {'value': '8', 'spread': '3', 'groupId': 'BG001'}, {'value': '8', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', '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': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-08', 'studyFirstSubmitDate': '2010-04-19', 'resultsFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-08', 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Mass Index', 'timeFrame': 'Baseline', 'description': 'left ventricular mass index measured by 2D echocardiography'}, {'measure': 'Fractional Shortening', 'timeFrame': 'Baseline', 'description': 'Fractional shortening measured by M-mode cardiography'}], 'secondaryOutcomes': [{'measure': 'Global Strain Rate', 'timeFrame': 'Baseline', 'description': 'Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography'}, {'measure': "Systolic Myocardial Velocity During Systole (S')", 'timeFrame': 'Baseline', 'description': 'Systolic myocardial velocity during systole measured by tissue Doppler echocardiography'}, {'measure': 'Early to Late Diastolic Filling Ratio', 'timeFrame': 'Baseline', 'description': 'Early to late diastolic filling ratio measured by tissue Doppler echocardiography'}, {'measure': 'Myocardial Wall Velocity During Early Diastole', 'timeFrame': 'Baseline', 'description': 'Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'heart function', 'HAART', 'in utero', 'children'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '22874520', 'type': 'RESULT', 'citation': 'Cade WT, Waggoner AD, Hubert S, Krauss MJ, Singh GK, Overton ET. Reduced diastolic function and left ventricular mass in HIV-negative preadolescent children exposed to antiretroviral therapy in utero. AIDS. 2012 Oct 23;26(16):2053-8. doi: 10.1097/QAD.0b013e328358d4d7.'}]}, 'descriptionModule': {'briefSummary': 'HIV-uninfected children born to HIV+ women have low level heart problems at birth which may predispose them to heart failure, arrythmias and heart attack later in life. The impact of these heart problems on future heart health is unclear as it is unknown if heart problems in these children persist, worsen or resolve in pre-pubescence. The objective of this study is to characterize heart function in HIV-negative pre-pubertal children born to HIV+ women and exposed to HIV and HAART in utero and compare them to age and gender matched healthy children born to HIV-negative women. Through this objective we will determine if heart problems in HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or resolves during pre-pubescence.', 'detailedDescription': 'Significance:\n\nApproximately 700,000 children annually are born to HIV-infected mothers throughout the world, but with the advent of perinatal highly active antiretroviral therapy (HAART), the majority of children are born uninfected in Westernized nations and those uninfected are increasing in developing nations. Uninfected children exposed to HIV and HAART in utero, have subclinical left ventricular dysfunction (LVD) at birth which may predispose them to heart failure, conduction abnormalities and myocardial infarction later in life. The impact of this LVD on future cardiac risk is unclear as it is unknown if LVD in these children persist, worsen or resolve in pre-pubescence.\n\nStudy objectives:\n\nThe objective of this study is to characterize left ventricular function in HIV-negative pre-pubertal children born to HIV+ women and exposed to HIV and HAART in utero and compare them to age and gender matched healthy children born to HIV-negative women. Through this objective we will determine if LVD in HIV-negative children born to HIV+ women and exposed to HAART in utero persists, worsens, or resolves during pre-pubescence. If LVD persists or worsens in pre-pubescence, these data will lead to future studies examining mechanisms of and treatments for LVD in these children and will significantly impact the clinical monitoring and care of these children. If LVD resolves during pre-pubescence, then these data will provide important information that clinical cardiac monitoring may not be critical in this population.\n\nMethods:\n\nWe plan to examine left ventricular function in 30 HIV-negative children born to HIV+ women and exposed to HAART in utero and compare them to 30 healthy age and gender matched children born to HIV-negative women. Left ventricular function will be examined by 2-D, Doppler and Tissue Doppler imaging echocardiography using a General Electric Vivid 7® ultrasound machine. Left ventricular measures will include left ventricular structure and dimensions, systolic and diastolic flow rates, wall velocities during systole and diastole and systolic and diastolic strain and strain rates (sensitive measures of myocardial contractility). Echocardiographic measures will take place in the Cardiovascular Imaging Laboratory (CVIL) at Washington University School of Medicine by a certified cardiac ultrasonographer and data will be processed, analyzed and interpreted by the ultrasonographer, a consulting cardiologist and the principal investigator.\n\nOutcomes:\n\nPrimary outcomes will include measures of left ventricular function: left ventricular mass, left ventricular end diastolic dimension, fractional shortening, systolic and diastolic wall velocities (tissue Doppler imaging) and systolic and diastolic strain and strain rates (2-D speckle tracking methodology).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-negative children will be recruited through their HIV+ mothers who are seen at the AIDS Clinical Trials Unit at Washington University and surrounding St. Louis community clinics. HIV-negative children will be recruit through Washington University and surrounding St. Louis pediatric clinics, and through Washington University Volunteers for Health service.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 5-12 years\n2. Tanner stage I-III\n3. Born to HIV+ mother\n4. No HIV infection\n5. Had taken standard of care prophylactic HAART at birth-1 month of age\n6. Child currently not taking medications or have medical diagnosis that would affect left ventricular function\n7. Mother was taking HAART during pregnancy (standard of care)\n8. Mother was not using illegal drugs during pregnancy\n9. No intrauterine growth restriction diagnosis during pregnancy\n10. During pregnancy, mother will not have a diagnosis of type 2 diabetes or gestational diabetes.\n\nExclusion Criteria:\n\n1. Age 5-12 years\n2. Tanner stage I-III\n3. Born to HIV-negative mother\n4. Mother was not a frequent exerciser during pregnancy (\\>2x/week)\n5. Mother will not have gestational diabetes or a diagnosis of type 2 diabetes during pregnancy of the child being studied\n6. Child currently not taking medications or have medical diagnosis that would affect left ventricular function'}, 'identificationModule': {'nctId': 'NCT01107834', 'briefTitle': 'Heart Function in HIV-Negative Children Exposed to HIV and HAART', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Left Ventricular Function in HIV-Negative Children Exposed to HIV and HAART In Utero', 'orgStudyIdInfo': {'id': '10-0121'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Control', 'description': 'HIV-negative children born to healthy, HIV-negative women'}, {'label': 'Exposed to HIV/HAART', 'description': 'HIV-negative children exposed to HIV and HAART in utero'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'William T Cade, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Physical Therapy and Medicine', 'investigatorFullName': 'W. Todd Cade', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}