HIV Vertical Transmission in Vietnam

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669604
• Other study ID #: 3RF-1
• Secondary ID: 3RF-1/MoST-Sida
• Status: Completed
• Phase: N/A
• First received: April 28, 2008
• Last updated: April 29, 2008
• Start date: March 2004
• Est. completion date: December 2007

Study information

• Verified date: April 2008
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Vietnam	Obstetric and Gynaecology Hospital	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Hygiene and Epidemiology, Vietnam	Karolinska Institutet

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV-infection in the children.		2004 - 2007	Yes
Secondary	Mortality in the children in the first 18 months		completed 2007	Yes
Secondary	Safety of formula feeding measured by the mortality by 18 months		Completed by end of 2007	Yes