Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341302
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2006-06-19
Brief Title:
A Prospective Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Observational Study of HIV-Infected Pregnant Women and HIV-Exposed Uninfected Children at Clinical Sites in Latin American Countries
Status:
COMPLETED
Status Verified Date:
2020-07
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:
By the end of 1999 it was estimated that 12 million children were living with HIV infection During 1999 alone 600000 children were newly infected with HIV mostly in less-developed countries Most HIV-infected children are infected by transmission from mother to child during pregnancy at birth or through breast milk Antiretroviral medications cesarean section before rupture of membranes and avoidance of breastfeeding are ways to reduce the risk of transmission This study will determine mother-to-child transmission rates and the effects on infants of exposure to antiretroviral medications and mode of delivery
Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study HIV-infected women will be evaluated during pregnancy during delivery and 6 months after delivery At each visit a history will be taken and physical examination given blood will be collected for laboratory tests
HIV-exposed infants will be evaluated through 6 months of age At each of 2 visits a history will be taken and physical examination given blood will be collected for laboratory tests and growth will be assessed
Approximately 180 to 240 HIV-infected pregnant women in Mexico and Argentina will be enrolled during the first year of this 5-year study HIV-infected women will be evaluated during pregnancy during delivery and 6 months after delivery At each visit a history will be taken and physical examination given blood will be collected for laboratory tests
HIV-exposed infants will be evaluated through 6 months of age At each of 2 visits a history will be taken and physical examination given blood will be collected for laboratory tests and growth will be assessed
Detailed Description:
This is an observational prospective cohort study to describe the characteristics of HIV-infected pregnant women and HIV-exposed uninfected children at participating clinical sites in Latin America where the following are available 1 antiretrovirals ARVs for treatment of HIV-infected women and for prevention of mother-to-child transmission MTCT of HIV and 2 infant formula We will describe the utilization of interventions related to decreasing the risk of MTCT including ARV prophylaxis cesarean section before labor and before ruptured membranes and complete avoidance of breastfeeding We will describe receipt of maternal ARV regimens and determine rates of MTCT of HIV This study will describe maternal adverse events during pregnancy and the postpartum period In addition the study will describe child outcomes potentially related to in utero and early postnatal exposure to ARVs HIV-infected women will be evaluated antepartum intrapartum 6 months postpartum and then every 6 months for up to 5 years after delivery HIV-exposed uninfected children will be evaluated for up to 5 years of follow-up
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CH-N261 | None | None | None |