HIV Vertical Transmission in Vietnam
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Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam |
- HIV-infection in the children. [ Time Frame: 2004 - 2007 ] [ Designated as safety issue: Yes ]
- Mortality in the children in the first 18 months [ Time Frame: completed 2007 ] [ Designated as safety issue: Yes ]
- Safety of formula feeding measured by the mortality by 18 months [ Time Frame: Completed by end of 2007 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
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.
| Enrollment: | 135 |
| Study Start Date: | March 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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
- 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.
- 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).
- Selective cesarean section not comment for HIV pregnant women.
- 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.
- Two HIV infected child die before 18months versus non die in uninfected child.
- CD4 T cell count lower than 200/microliter were observed dominate in mother infected child.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
- 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.
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:
- The child had less than 3 time to test.
Contacts and Locations| Vietnam | |
| Obstetric and Gynaecology Hospital | |
| Hanoi, Vietnam, 10000 | |
| Study Chair: | Phung D Cam, MD,PhD | National Institute of Hygiene and Epidemiology, Vietnam |
More Information
Publications:
| Responsible Party: | Phung Dac Cam, National Institute of Hygiene and Epidemiology |
| ClinicalTrials.gov Identifier: | NCT00669604 History of Changes |
| Other Study ID Numbers: | 3RF-1, 3RF-1/MoST-Sida |
| Study First Received: | April 28, 2008 |
| Last Updated: | April 29, 2008 |
| Health Authority: | Vietnam: Ministry of Health |
Keywords provided by National Institute of Hygiene and Epidemiology, Vietnam:
|
Mother to child transmission of HIV HIV infected children |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013
