Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-05 @ 12:55 AM
Study NCT ID:
NCT00669604
Status:
COMPLETED
Last Update Posted:
2008-04-30
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIV Vertical Transmission in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral EDTA blood samples were collected from the child at birth (1-2 days), at 1, 3, 6, 12, and 18 months of age and processed at the Molecular Laboratory in the Hanoi Obstetric and Gynaecology hospital. The maternal blood samples were taken at the same day as the first sample of their child. Three ml EDTA blood was taken from the mother and 2 ml from the child. The blood was processed within 8 hours. Cells and plasma were stored separately at - 20 Celcius degree.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-29', 'studyFirstSubmitDate': '2008-04-28', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV-infection in the children.', 'timeFrame': '2004 - 2007'}], 'secondaryOutcomes': [{'measure': 'Mortality in the children in the first 18 months', 'timeFrame': 'completed 2007'}, {'measure': 'Safety of formula feeding measured by the mortality by 18 months', 'timeFrame': 'Completed by end of 2007'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mother to child transmission of HIV', 'HIV infected children'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Tran Thi Thanh Ha, Pham Le Tuan, Nguyen Huy Bao et al. Successful reduction of mother-to-child transmission of HIV-1 by nevirapin and non-breastfeeding in Hanoi and Haiphong. Retrovirology 2008; 5, S1: 26-27.'}]}, 'descriptionModule': {'briefSummary': 'Prevention of HIV-1 transmission from mother-to-child by non-breast-feeding is complicated by increased infant mortality in developing countries. However, extensive counselling about formula feeding turned out safe in Vietnam, a middle-income country.Extensive counselling together with formula feeding and antiretroviral therapy reduced vertical transmission of HIV-1 considerably.', 'detailedDescription': 'Observation 135 HIV mother to check up and delivery in the Obstetric and Gynecology in two big city in Northern Vietnam (Hanoi and Haiphong)and follow up their children from the birth to 18 months. They were provide the antiretroviral by the National program for prevention of mother-to-child transmission of HIV, also the counseling estimates 6 hours for each mother-child pair while study progressing. Using the Nested PCR to diagnosis HIV infected in the children in difference time point before 18 months. Our Outcome are\n\n* The rate of HIV transmission form mother to child in our study is 6,7%(9?135). In utero is 1,5% and 5% in gestation.\n* Sixty-nine percent of HIV pregnant women were get antiretroviral. Most of them (84%) get nevirapine at delivery (6 children HIV infected). The rest get triple antiretroviral(2 infected child).\n* Selective cesarean section not comment for HIV pregnant women.\n* Non breast feeding were recommended and all mothers chose formula feeding to their child so that we had no data for transmission by breast milk.\n* Two HIV infected child die before 18months versus non die in uninfected child.\n* CD4 T cell count lower than 200/microliter were observed dominate in mother infected child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-1 infected pregnant women were identified in the Obstetric and Gynaecology hospitals in Hanoi (2004-2007) and Haiphong (2006-2007).\n\nThey were encouraged to participate in a prospective study with regular clinical follow up of their children from birth to 12-18 months of age. All participants signed an informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV Mother willing to enroll to study and their child For mother: Their HIV status was diagnosed by at least one quick test and two different ELISA serological tests.\n\nFor their child: the child had tested HIV at list 3 time one at birth, one at 12 or 18 months and one in between.\n\nExclusion Criteria:\n\n* The child had less than 3 time to test.'}, 'identificationModule': {'nctId': 'NCT00669604', 'briefTitle': 'HIV Vertical Transmission in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Hygiene and Epidemiology, Vietnam'}, 'officialTitle': 'Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam', 'orgStudyIdInfo': {'id': '3RF-1'}, 'secondaryIdInfos': [{'id': '3RF-1/MoST-Sida'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'Obstetric and Gynaecology Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Phung D Cam, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of Hygiene and Epidemiology, Vietnam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Hygiene and Epidemiology, Vietnam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Phung Dac Cam', 'oldOrganization': 'National Institute of Hygiene and Epidemiology'}}}}