Clinical trial NCT00669604: HIV Vertical Transmission in Vietnam
Official title: Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Mother to child transmission of HIV
HIV infected children
Lead sponsor: National Institute of Hygiene and Epidemiology, Vietnam
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2008-04-30
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: HIV-infection in the children.
timeFrame: 2004 - 2007
Secondary outcomes:
measure: Mortality in the children in the first 18 months
timeFrame: completed 2007
measure: Safety of formula feeding measured by the mortality by 18 months
timeFrame: Completed by end of 2007
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Obstetric and Gynaecology Hospital
Study officials:
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Phung D Cam, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.