Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-04 @ 12:34 PM
Study NCT ID:
NCT03642704
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective non-comparative study of mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before birth or whose HIV infection has been diagnosed at birth. Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth among infants at high risk of infection with HIV.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-21', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measure the clinical tolerance of reinforced preventive antiretroviral treatment in children', 'timeFrame': 'Week 12', 'description': '• Nature of clinical adverse events'}, {'measure': 'Measure the biological tolerance of reinforced preventive antiretroviral treatment in children', 'timeFrame': 'Week 12', 'description': '• Nature of biological adverse events'}, {'measure': 'Measure the proportion of children on reinforced preventive antiretroviral treatment with anemia', 'timeFrame': 'Week 12', 'description': '• Proportion of children with anemia superior or equal to grade 2'}, {'measure': 'Measure the proportion of children who change antiretroviral therapy for grade 4 adverse event', 'timeFrame': 'Week 12', 'description': '• Proportion of children who change antiretroviral therapy for grade 4 adverse event'}, {'measure': 'Measure the proportion of children with preventive antiretroviral treatment interruption', 'timeFrame': 'Week 12', 'description': '• Proportion of children with preventive antiretroviral treatment interruption'}, {'measure': 'Describe the clinical events occurring in mothers', 'timeFrame': 'Week 72', 'description': '• Description of clinical events occurring in mothers'}, {'measure': 'Measure the proportion of mothers presenting clinical events', 'timeFrame': 'Week 72', 'description': '• Proportion of mothers presenting clinical events'}, {'measure': 'Describe the immunological outcomes in mothers', 'timeFrame': 'Week 72', 'description': '• Value of CD4 (absolute number)'}, {'measure': 'Describe the virological outcomes in mothers', 'timeFrame': 'Week 72', 'description': '• Value of HIV RNA (copies/mL)'}, {'measure': 'Describe the clinical outcomes in HIV-infected children', 'timeFrame': 'Week 48', 'description': '• Description of clinical events occurring in HIV-infected children'}, {'measure': 'Measure the proportion of HIV-infected children presenting clinical events', 'timeFrame': 'Week 48', 'description': '• Proportion of HIV-infected children presenting clinical events'}, {'measure': 'Describe the immunological outcomes in HIV infected children', 'timeFrame': 'Week 48', 'description': '• Value of CD4 (absolute number)'}, {'measure': 'Describe the virological outcomes in HIV infected children', 'timeFrame': 'Week 48', 'description': '• Value of HIV RNA (copies/mL)'}, {'measure': 'Describe the clinical outcomes in HIV-non-infected children', 'timeFrame': 'Week 72', 'description': 'Nature of clinical events occurring in HIV-non-infected children'}, {'measure': 'Measure the proportion of HIV-non-infected children presenting clinical events', 'timeFrame': 'Week 72', 'description': '• Proportion of HIV-non-infected children presenting clinical events'}, {'measure': 'Describe the rate of mother to child transmission of HIV', 'timeFrame': 'Week 72', 'description': '• Proportion of HIV infected children (based on PCR ADN or ARN)'}, {'measure': 'Describe the risk factors of mother to child transmission of HIV', 'timeFrame': 'week 72', 'description': 'Description of risk factors for HIV transmission'}], 'primaryOutcomes': [{'measure': 'Proportion of newborns who have received an HIV diagnosis and reinforced preventive antiretroviral treatment at birth.', 'timeFrame': 'Day 2', 'description': 'Proportion of newborns who have received both HIV test and reinforced preventive antiretroviral treatment in a maximum of 48 hours after birth.'}], 'secondaryOutcomes': [{'measure': 'Proportion of mothers diagnosed with HIV who will initiate an antiretroviral therapy', 'timeFrame': 'Week 72', 'description': '• Proportion of mothers diagnosed with HIV at Day 0 who will initiate an antiretroviral therapy'}, {'measure': 'Proportion of children diagnosed with HIV who will initiate an antiretroviral therapy', 'timeFrame': 'Week 72', 'description': '• Proportion of children diagnosed with HIV from Day 0 to Week 72 who will initiate an antiretroviral therapy'}, {'measure': 'Proportion of mother-child pairs retained in the study with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment', 'timeFrame': 'Week 24', 'description': '• Proportion of mother-child pairs retained in the study from Day 0 to Week 24 with child having 2 PCR performed after stopping reinforced preventive antiretroviral treatment'}, {'measure': 'Proportion of mother-child pairs retained in the study', 'timeFrame': 'Week 72', 'description': '• Proportion of mother-child pairs retained in the study from Day 0 to Week 72.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PMTCT', 'HIV early diagnosis', 'HIV preventive therapy', 'prevention of mother to child HIV transmission'], 'conditions': ['Mother to Child HIV Transmission']}, 'descriptionModule': {'briefSummary': 'Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth\\* among infants at high risk of infection with HIV\\*\\* .\n\n* in a maximum of 48 hours after delivery\n\n * born from HIV infected mothers who received less than 4 weeks of antiretroviral therapy prior delivery and / or HIV infection diagnosed at delivery\n\nIntervention, a combined strategy :\n\nAfter positive HIV infection screening from mother in the delivery room and put on antiretroviral treatment of mothers with post partum according to national guidelines , newborns benefit :\n\n* Early detection of HIV infection at birth\n* Without awaiting the outcome of early detection result, a preventive reinforced antiretroviral treatment (zidovudine, lamivudine, nevirapine or zidovudine, lamivudine if their mother is infected with HIV-2), from birth for 12 weeks.\n* Regular HIV screening until the end of breastfeeding or later to 18 months.\n* In case of positive results of an HIV test, an antiretroviral treatment with zidovudine, lamivudine, lopinavir, ritonavir whatever serology HIV 1 or 2.', 'detailedDescription': 'Objectives Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth\\* among infants at high risk of infection with HIV\\*\\* .\n\n\\* in a maximum of 48 hours after delivery\n\n\\*\\*born from HIV infected mothers who received less than 4 weeks of antiretroviral therapy prior delivery and / or HIV infection diagnosed at delivery Secondary objectives\n\n* Measure the cascade management of HIV infected mothers and HIV infected infants\n* Measure the tolerance of reinforced preventive antiretroviral treatment\n* Describe the rate of mother to child transmission of HIV and its risk factors\n* Describe the clinical and immuno-virologic outcomes in mothers, in HIV infected children and in HIV-non-infected children\n* Evaluate the acceptability of the strategy by mothers and caregivers.\n* Compare the early diagnosis of HIV infection with Abbott and Biocentric HIV RNA tests\n\nMethodology Prospective non-comparative study of mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before birth or whose HIV infection has been diagnosed at birth.\n\nEstimated enrolment: 300 mother-child pairs\n\nEligibility:\n\nInclusion criteria:\n\nMother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before delivery or whose HIV infection has been diagnosed at delivery Mother who signed the informed consent form to participate in the study.\n\nnon-inclusion criteria: Mother treated with antiretrovirals during the month preceding delivery No inclusion for precautionary reason : clinical symptoms suggesting an opportunistic infection of the central nervous system.\n\nNo inclusion for monitoring difficulties History or presence of allergy to the study drugs or their components Contra-indications to the study drugs Symptoms, physical signs or laboratory values suggestive of systemic disorders, (including renal, hepatic, cardiovascular, pulmonary, skin, or psychiatric and other conditions, which could interfere with the interpretation of the trial results\n\nIntervention, a combined strategy :\n\nAfter positive HIV infection screening from mother in the delivery room and put on antiretroviral treatment of mothers with post partum according to national guidelines , newborns benefit :\n\n* Early detection of HIV infection at birth\n* Without awaiting the outcome of early detection result, a preventive reinforced antiretroviral treatment (AZT / 3TC / NVP or AZT / 3TC if their mother is infected with HIV -2), from birth for 12 weeks.\n* Regular HIV screening until the end of breastfeeding or later to 18 months.\n* In case of positive results of an HIV test, an antiretroviral treatment with AZT / 3TC / LPV whatever serology HIV 1 or 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mother-child pairs whose mother is HIV-infected and received less than 4 weeks of antiretroviral therapy before delivery or whose HIV infection has been diagnosed at delivery\n* Mother who signed the informed consent form to participate in the study.\n\nExclusion Criteria:\n\n* Mother treated with antiretrovirals during the month preceding delivery\n* No inclusion for precautionary reason : clinical symptoms suggesting an opportunistic infection of the central nervous system.\n* No inclusion for monitoring difficulties\n* History or presence of allergy to the study drugs or their components\n* Symptoms, physical signs or laboratory values suggestive of systemic disorders, (including renal, hepatic, cardiovascular, pulmonary, skin, or psychiatric and other conditions, which could interfere with the interpretation of the trial results'}, 'identificationModule': {'nctId': 'NCT03642704', 'acronym': 'DIAVINA', 'briefTitle': 'HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'HIV Diagnosis and Treatment at Birth for HIV Exposed Newborn Whose Mother Was Not Treated With Antiretroviral Therapy (ART) During Last Month Before Delivery : Strategy Evaluation in Guinea.', 'orgStudyIdInfo': {'id': 'ANRS12344-DIAVINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reinforced preventive ARV therapy', 'description': 'The proposed reinforced preventive ARV Therapy will be administrated to all newborns exposed to HIV (zidovudine+lamivudine+nevirapine if the newborn is exposed to HIV-1 or HIV-1/2, zidovudine+lamivudine if the newborns exposed to HIV-2)', 'interventionNames': ['Drug: Reinforced preventive ARV therapy']}], 'interventions': [{'name': 'Reinforced preventive ARV therapy', 'type': 'DRUG', 'otherNames': ['Early diagnosis in children exposed to HIV'], 'description': 'If the mother is HIV-1 or HIV 1/2 infected:\n\n* zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks.\n* nevirapine: 15mg/OD if weight ≥ 2500g / 10mg/OD if weight = 2000-2499g / 2mg/kg/OD if weight \\< 2000g for 12 weeks in case of HIV-1 infection. After 6 weeks, nevirapine will increase at 20mg/OD\n\nIf the mother is HIV-2 infected:\n\n\\- zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks.', 'armGroupLabels': ['Reinforced preventive ARV therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Conakry', 'country': 'Guinea', 'facility': 'Hôpital National Ignace Deen', 'geoPoint': {'lat': 9.53795, 'lon': -13.67729}}], 'overallOfficials': [{'name': 'Guillaume Breton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Solthis'}, {'name': 'Mohamed Cisse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Donka'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}