NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries

Completed

• Conditions: HIV

• Registration Number: NCT00339612
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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 Timeline

• Study Start: 2002-07-30
• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-21
• Primary Completion: 2011-12-30
• Status Verified: 2020-07
• Study Completion: 2020-07-28
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2129

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Brazil

Hospital Femina; 🇧🇷 Porto Alegre, Brazil

Ricardo de Souza STD/HIV Clinic-Caxias do Sul; 🇧🇷 Caxias do Sul, Brazil

Hospital Conceicao; 🇧🇷 Porto Alegre, Brazil

Hospital de Clinicas; 🇧🇷 Porto Alegre, Brazil

Hospital dos Servidores do Estado; 🇧🇷 Rio de Janeiro, Brazil

Instituto de Puericultura e Pediatria Martagao Gesteira; 🇧🇷 Rio de Janeiro, Brazil

Instituto de Infectologica Emilio Ribas (IIER); 🇧🇷 San Paulo, Brazil

Hospital das Clinicas da Falculdade De Medinica; 🇧🇷 Sao Paulo, Brazil

Federal University of Sao Paulo-Escola Paulista de Medicina; 🇧🇷 Sao Paulo, Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre; 🇧🇷 Porto Alegre, Brazil

Hospital Geral Nova de Iguacu; 🇧🇷 Rio de Janeiro, Brazil

Hospital Infantil de Mexico Federico Gomez (HIM); 🇲🇽 Mexico City, Mexico

University of San Marcos; 🇵🇪 Lima, Peru