Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02406768
Status:
COMPLETED
Last Update Posted:
2015-04-02
First Post:
2014-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Sub-study of PREDICT Neurodevelopment Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurodevelopment changes (composite of cognitive, fine motor and behavioral)', 'timeFrame': 'up to 96 weeks', 'description': 'measured by cognitive test, fine motor test and behavioral assessment test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['normal controls'], 'conditions': ['Neurocognitive Development']}, 'referencesModule': {'references': [{'pmid': '23263176', 'type': 'RESULT', 'citation': 'Puthanakit T, Ananworanich J, Vonthanak S, Kosalaraksa P, Hansudewechakul R, van der Lugt J, Kerr SJ, Kanjanavanit S, Ngampiyaskul C, Wongsawat J, Luesomboon W, Vibol U, Pruksakaew K, Suwarnlerk T, Apornpong T, Ratanadilok K, Paul R, Mofenson LM, Fox L, Valcour V, Brouwers P, Ruxrungtham K; PREDICT Study Group. Cognitive function and neurodevelopmental outcomes in HIV-infected Children older than 1 year of age randomized to early versus deferred antiretroviral therapy: the PREDICT neurodevelopmental study. Pediatr Infect Dis J. 2013 May;32(5):501-8. doi: 10.1097/INF.0b013e31827fb19d.'}], 'seeAlsoLinks': [{'url': 'http://www.hivnat.org', 'label': 'HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'}]}, 'descriptionModule': {'briefSummary': 'To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).', 'detailedDescription': 'Normative data are mostly, if not exclusively, obtained from children in the Western world. Comparing data from Asian children to these norms may lead to the wrong interpretation of the results, as it does not account for cultural differences, translation issues and a possibly different education system. Therefore it is essential to include a matched control group to evaluate the participants of the study to the fullest extent in terms of cognition, memory, behavior and fine motor skills, in all age groups over the full course of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV negative unexposed and HIV-negative children born to HIV-infected mothers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: for HIV negative exposed children\n\n* Child from a HIV-positive mother\n* Documented negative test for HIV-1 infection\n* Between the age from 1-15 years\n* Caregiver of the subject is willing and able to sign informed consent, prior to the study\n* Thai or Cambodian origin\n\nHIV negative and not HIV exposed:\n\nInclusion\n\n* Child from a HIV-negative mother (by history)\n* Documented negative test for HIV-1 infection\n* Between the age from 1-15 years\n* Caregiver of the subject is willing and able to sign informed consent, prior to the study\n* Thai or Cambodian origin\n\nExclusion Criteria: for HIV negative exposed children\n\n* The inability of the caregivers to understand the nature and extend of the trial and the procedure required\n* Patients with psychiatric disorder\n* Patients with a syndrome that affects cognitive performance\n\nfor HIV negative and not HIV exposed\n\n* The inability of the caregivers to understand the nature and extent of the trial and the procedure required\n* Patients with psychiatric disorder\n* Patients with a syndrome that affects cognitive performance'}, 'identificationModule': {'nctId': 'NCT02406768', 'briefTitle': 'A Sub-study of PREDICT Neurodevelopment Protocol', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'The Neurodevelopment in Normal Children in Cambodia and Thailand', 'orgStudyIdInfo': {'id': 'HIV-NAT 035.4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV negative unexposed', 'description': 'HIV negative controls'}, {'label': 'HIV negative exposed', 'description': 'HIV-negative children born to HIV-infected mothers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'National Center for HIV/AIDS, Dermatology and STDs (NCHADS)', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'National Pediatric Hospital', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '22000', 'city': 'Chanthaburi', 'state': 'Changwat Chanthaburi', 'country': 'Thailand', 'facility': 'Prapokklao Hospital', 'geoPoint': {'lat': 12.60961, 'lon': 102.10447}}, {'zip': '57000', 'city': 'Chiang Rai', 'state': 'Changwat Chiang Rai', 'country': 'Thailand', 'facility': 'Chiangrai Regional Hospital', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'zip': '20110', 'city': 'Chon Buri', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Queen Savang Vadhana Memorial Hospital, Pediatric Department,', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}, {'zip': '40002', 'city': 'Khon Kaen', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Department of Pediatrics Faculty of Medicine Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '11000', 'city': 'Nonthaburi', 'state': 'Changwat Nonthaburi', 'country': 'Thailand', 'facility': 'Bamrasnaradura Institute', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}, {'zip': '50180', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Nakornping Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Kiat Ruxrungtham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The HIV Netherlands Australia Thailand Research Collaboration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}