Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339612
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2006-06-19
Brief Title:
NISDI Pediatric Latin American Countries Epidemiologic Study PLACES A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American 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:
NISDI Pediatric Latin American Countries Epidemiologic Study PLACES A Prospective Observational Study of HIV-Infected 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:
This is an observational prospective cohort study to describe the demographic clinical immunologic and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission MTCT The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol The second cohort will be a dynamic cohort of prospectively enrolled HIV-infected children who are five years of age or younger We will characterize complications from both the disease and its treatments Subjects will be evaluated every six months for approximately five years and assessments of growth morbidity disease progression and mortality will be made
Detailed Description:
This is an observational prospective cohort study to describe the demographic clinical immunologic and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries Enrollment in this study will consist of approximately 500 HIV-infected children in two cohorts who acquired HIV infection through mother-to-child transmission MTCT The first group will be a static cohort consisting of HIV-infected children who were five years of age or younger when previously enrolled into the NISDI Pediatric Protocol The second cohort will be a dynamic cohort of prospectively enrolled HIV-infected children who are five years of age or younger We will characterize complications from both the disease and its treatments Subjects will be evaluated every six months for approximately five years and assessments of growth morbidity disease progression and mortality will be made
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-N270 | None | None | None |