NCT00339612

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
• Phase: —
• Study type: Observational
• Enrollment: 2,129 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Timeline

• Start date: 2002-07-30
• Primary completion: 2011-12-30
• Completion: 2020-07-28
• First posted: 2006-06-21
• Last updated: 2020-07-30

Locations

14 sites across 3 countries: Brazil, Mexico, Peru