Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-30 @ 11:15 PM
Study NCT ID:
NCT05393193
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-19
First Post:
2022-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POC HIV Testing and Early DTG Use for Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of high-risk HIV-exposed infants identified and tested', 'timeFrame': 'within 72 hours of life', 'description': 'Analysis will largely be descriptive, highlighting the proportion of high-risk infants identified and tested at each facility. Proportions will be determined by populating actual numbers approached and screened matched against exact denominators obtained from surveillance data.'}, {'measure': 'Median time to HIV diagnosis and treatment-dose ART', 'timeFrame': '7 days', 'description': 'We will describe the proportion of high-risk infants found to be HIV positive per risk category and compare this to findings from another cohort study of early-treated children. Average time to HIV diagnosis and treatment initiation will also be described.'}, {'measure': 'The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART', 'timeFrame': '12 weeks on ART', 'description': 'We will compare time to viral suppression and the proportion with complete HIV-1 RNA suppression (\\<40 copies/mL) at 12 weeks from ART start between infants on early DTG with another cohort of children on early LPV/r.'}, {'measure': 'The proportion of children with successful DTG-based treatment through 96 weeks on ART', 'timeFrame': '96 weeks on ART', 'description': 'We will compare the proportion with complete HIV-1 RNA suppression and no need for treatment modification at all visits through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.'}, {'measure': 'The proportion of infants with grade 3 or 4 adverse events/hospitalization/death', 'timeFrame': '96 weeks on ART', 'description': 'We will compare the proportion with grade 3 or 4 adverse events through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for point-of-care infant HIV testing:\n\n1. Mother 18 years of age or older\n2. Mother willing and able to provide verbal consent for infant testing\n3. Infant birth weight ≥1.5kg\n4. Presence of any of the following risk factors:\n\n\\<12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time \\>24 weeks gestation in pregnancy; CD4 cell count known to be \\<350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)\n\nExclusion criteria for point-of-care infant HIV testing:\n\n1\\) Medical condition making it unlikely that the infant will survive to 24 months\n\nInclusion criteria for infant longitudinal treatment cohort:\n\n1. Mother 18 years of age or older\n2. Mother willing and able to provide written informed consent for study participation for herself and her infant\n3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)\n4. Infant eligible for ART treatment in accordance with the Botswana government program\n5. Infant birth weight ≥1.5 kg\n\nExclusion criteria for infant longitudinal treatment cohort:\n\n1. Medical condition making it unlikely that the infant will survive to 24 months\n2. Infant unable to start treatment-dose ART \\< 168 hours of age\n3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown'}, 'identificationModule': {'nctId': 'NCT05393193', 'briefTitle': 'POC HIV Testing and Early DTG Use for Infants', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Point-of-Care HIV Testing and Early Dolutegravir Use for Infants', 'orgStudyIdInfo': {'id': '155BHP'}, 'secondaryIdInfos': [{'id': 'P01HD107670', 'link': 'https://reporter.nih.gov/quickSearch/P01HD107670', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HIV-exposed neonates', 'description': 'Point-of-care HIV testing at birth', 'interventionNames': ['Diagnostic Test: Point-of-Care Cepheid Xpert HIV-1']}, {'type': 'OTHER', 'label': 'HIV-positive infants identified through birth HIV screening', 'description': 'Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg.', 'interventionNames': ['Drug: DTG/ABC/3TC']}], 'interventions': [{'name': 'Point-of-Care Cepheid Xpert HIV-1', 'type': 'DIAGNOSTIC_TEST', 'description': 'Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis.', 'armGroupLabels': ['HIV-exposed neonates']}, {'name': 'DTG/ABC/3TC', 'type': 'DRUG', 'description': 'Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines.', 'armGroupLabels': ['HIV-positive infants identified through birth HIV screening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Botswana Harvard HIV/AIDS Institute Partnership', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}], 'overallOfficials': [{'name': 'Roger L Shapiro, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Botswana Harvard AIDS Institute Partnership', 'class': 'OTHER'}, {'name': 'Ragon Institute of MGH, MIT and Harvard', 'class': 'OTHER'}, {'name': 'Botswana Ministry of Health', 'class': 'OTHER_GOV'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Immunology and Infectious Diseases', 'investigatorFullName': 'Roger Shapiro', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}