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
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Hygiene and Epidemiology, Vietnam:

Primary Outcome Measures:
  • HIV-infection in the children. [ Time Frame: 2004 - 2007 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
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.
  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669604

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

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.

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 August 18, 2014