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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00339612 |
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.
Condition |
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HIV |
Study Type: | Observational |
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 |
Estimated Enrollment: | 2500 |
Study Start Date: | July 2002 |
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Static Cohort:
HIV infection must be documented in the medical records by:
For children < 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
For children less than 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
Dynamic cohort:
HIV infection documented by:
For children < 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):
EXCLUSION CRITERIA:
Contact: Rohan Hazra, M.D. | (301) 435-4627 | hazrar@mail.nih.gov |
Brazil | |
Instituto de Puericultura e Pediatria Martagao Gesteira | Recruiting |
Rio de Janeiro, Brazil | |
Instituto de Infectologica Emilio Ribas (IIER) | Recruiting |
San Paulo, Brazil | |
Hospital dos Servidores do Estado | Recruiting |
Rio de Janeiro, Brazil | |
Sub-Investigator: Maria Leticia Santos Cruz, M.D. | |
Sub-Investigator: Aluce Loureiro Ouricuri, M.D. | |
Hospital Conceicao | Recruiting |
Porto Alegre, Brazil | |
Sub-Investigator: Breno Riegel Santos, M.D. | |
Ricardo de Souza STD/HIV Clinic-Caxias do Sul | Recruiting |
Caxias do Sul, Brazil | |
Hospital das Clinicas da Falculdade de Medinica de Ribeirao | Recruiting |
Sao Paulo, Brazil | |
Universidade Federal de Minas Gerais | Recruiting |
Belo Horizonte, Brazil | |
Hospital Femina | Recruiting |
Porto Alegre, Brazil | |
Sub-Investigator: Rosana Campos da Fonseca, M.D. | |
Hospital de Clinicas | Recruiting |
Porto Alegre, Brazil | |
Federal University of Sao Paulo-Escola Paulista de Medicina | Recruiting |
Sao Paulo, Brazil | |
Hospital Geral Nova de Iguacu | Recruiting |
Rio de Janeiro, Brazil | |
Irmandade Da Santa Casa de Misericordia de Porto Alegre | Recruiting |
Porto Alegre, Brazil | |
Mexico | |
Hospital Infantil de Mexico Federico Gomez (HIM) | Recruiting |
Mexico City, Mexico | |
Peru | |
University of San Marcos | Recruiting |
Lima, Peru |
Study ID Numbers: | 999902270, 02-CH-N270 |
Study First Received: | June 19, 2006 |
Last Updated: | October 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00339612 |
Health Authority: | United States: Federal Government |
AIDS Antiretroviral Outcomes Pediatric |
International HIV AIDS |
HIV Infections Acquired Immunodeficiency Syndrome |