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HIV Vertical Transmission in Vietnam

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by:
National Institute of Hygiene and Epidemiology, Vietnam
ClinicalTrials.gov Identifier:
NCT00669604
First received: April 28, 2008
Last updated: April 29, 2008
Last verified: April 2008

April 28, 2008
April 29, 2008
March 2004
December 2007   (final data collection date for primary outcome measure)
HIV-infection in the children. [ Time Frame: 2004 - 2007 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00669604 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
HIV Vertical Transmission in Vietnam
Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.

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.

HIV Infections
Not Provided
Not Provided
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.
 
Completed
135
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT00669604
3RF-1, 3RF-1/MoST-Sida
No
Phung Dac Cam, National Institute of Hygiene and Epidemiology
National Institute of Hygiene and Epidemiology, Vietnam
Karolinska Institutet
Study Chair: Phung D Cam, MD,PhD National Institute of Hygiene and Epidemiology, Vietnam
National Institute of Hygiene and Epidemiology, Vietnam
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP