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HIV Vertical Transmission in Vietnam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669604
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : April 30, 2008
Karolinska Institutet
Information provided by:
National Institute of Hygiene and Epidemiology, 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.

Condition or disease
HIV Infections

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

  • 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.

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Study Type : Observational
Actual Enrollment : 135 participants
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
Study Start Date : March 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. HIV-infection in the children. [ Time Frame: 2004 - 2007 ]

Secondary Outcome Measures :
  1. Mortality in the children in the first 18 months [ Time Frame: completed 2007 ]
  2. Safety of formula feeding measured by the mortality by 18 months [ Time Frame: Completed by end of 2007 ]

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669604

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Obstetric and Gynaecology Hospital
Hanoi, Vietnam, 10000
Sponsors and Collaborators
National Institute of Hygiene and Epidemiology, Vietnam
Karolinska Institutet
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Study Chair: Phung D Cam, MD,PhD National Institute of Hygiene and Epidemiology, Vietnam

Publications of Results:
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.

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Responsible Party: Phung Dac Cam, National Institute of Hygiene and Epidemiology Identifier: NCT00669604     History of Changes
Other Study ID Numbers: 3RF-1
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: April 30, 2008
Last Verified: April 2008

Keywords provided by National Institute of Hygiene and Epidemiology, Vietnam:
Mother to child transmission of HIV
HIV infected children

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases