Viewing Study NCT00669604


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Study NCT ID: NCT00669604
Status: COMPLETED
Last Update Posted: 2008-04-30
First Post: 2008-04-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: HIV Vertical Transmission in Vietnam
Sponsor: National Institute of Hygiene and Epidemiology, Vietnam
Organization:

Study Overview

Official Title: Counseling on Formula Feeding and Antiretroviral Prophylaxis Successfully Reduced Transmission of HIV-1 From Mother to Child in Northern Vietnam
Status: COMPLETED
Status Verified Date: 2008-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
3RF-1/MoST-Sida None None View