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Completed

NCT Number: NCT00669604

HIV Vertical Transmission in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HIV-infection in the children.

    Time frame: 2004 - 2007

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Apr 30, 2008
Registry last updated
Apr 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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