HIV Vertical Transmission in Vietnam
Tracking Information | |||||
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First Received Date ICMJE | April 28, 2008 | ||||
Last Updated Date | April 29, 2008 | ||||
Start Date ICMJE | March 2004 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
HIV-infection in the children. [ Time Frame: 2004 - 2007 ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00669604 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | HIV Vertical Transmission in Vietnam | ||||
Official Title ICMJE | Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam | ||||
Brief Summary | 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. |
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Detailed Description | 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
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | 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. |
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Sampling Method | Probability Sample | ||||
Study Population | HIV-1 infected pregnant women were identified in the Obstetric and Gynaecology hospitals in Hanoi (2004-2007) and Haiphong (2006-2007). They 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. |
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Condition ICMJE | HIV Infections | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 135 | ||||
Completion Date | December 2007 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
For their child: the child had tested HIV at list 3 time one at birth, one at 12 or 18 months and one in between. Exclusion Criteria:
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Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Vietnam | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669604 | ||||
Other Study ID Numbers ICMJE | 3RF-1, 3RF-1/MoST-Sida | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Phung Dac Cam, National Institute of Hygiene and Epidemiology | ||||
Study Sponsor ICMJE | National Institute of Hygiene and Epidemiology, Vietnam | ||||
Collaborators ICMJE | Karolinska Institutet | ||||
Investigators ICMJE |
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Information Provided By | National Institute of Hygiene and Epidemiology, Vietnam | ||||
Verification Date | April 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |