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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00339612
First received: June 19, 2006
Last updated: August 16, 2014
Last verified: July 2014
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Secondary Outcome Measures:
  • HIV RNA copies [ Time Frame: q 6 months ] [ Designated as safety issue: No ]
  • CD4 + T cell count [ Time Frame: q 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: July 2002
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Static Cohort:

  1. Previous participation in a NISDI Protocol
  2. Less then 6 years of age (before their 6th birthday) at the time of enrollment into the NISDI Pediatric Protocol
  3. HIV-infected
  4. HIV infection must be documented in the medical records by:

    1. For children less than 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

      • Positive HIV culture
      • Positive HIV DNA PCR
      • Positive neutralizable p24 antigen
      • Quantitative HIV RNA greater than or equal to 10,000 copies/ml
    2. For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

      • Reactive test for HIV antibody in a sample obtained at greater than or equal to 15 months of age with confirmatory test by Western Blot or Immunofluorescence assay
      • Positive HIV culture
      • Positive HIV DNA PCR
      • Positive neutralizable p24 antigen
      • Quantitative HIV RNA greater than or equal to 1,000 copies/ml
  5. Documentation of maternal HIV infection by country appropriate National Guidelines
  6. Signed informed consent from parent or legal guardian. An informed assent document will be provided for children 8 years of age or older when appropriate.
  7. Subjects must be able to be followed at a participating clinical site.
  8. Subjects may be co-enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV-related effects.

Dynamic cohort:

  1. HIV-infected less then 6 years of age (before their 6th birthday) at enrollment into this protocol
  2. HIV infection documented by:

    1. For children < 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

      • Positive HIV culture
      • Positive HIV DNA PCR
      • Positive neutralizable p24 antigen
      • Quantitative HIV RNA greater than or equal to 10,000 copies/ml
    2. For children greater than or equal to 18 months old when tested, two or more of the following (separate determinations on separate blood specimens):

      • Reactive test for HIV antibody in a sample obtained at greater than or equal to 15 months of age with confirmatory test by Western Blot or Immunofluorescence assay
      • Positive HIV culture
      • Positive HIV DNA PCR
      • Positive neutralizable p24 antigen
      • Quantitative HIV RNA greater than or equal to 1,000 copies/ml
  3. Documentation of maternal HIV infection by country appropriate National Guidelines
  4. Signed informed consent from parent or legal guardian. An informed assent document will be provided for children 8 years of age or older when appropriate.
  5. Subjects must be able to be followed at a participating clinical site
  6. Subjects may be co enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV related effects

EXCLUSION CRITERIA:

  1. Children who are born to an HIV infected mother, but are uninfected or of indeterminate HIV infection status
  2. Children who are orphans without legal guardians or are wards of the state
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339612

Locations
Brazil
Universidade Federal de Minas Gerais
Belo Horizonte, 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
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Hospital Femina
Porto Alegre, Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira
Rio de Janeiro, Brazil
Hospital Geral Nova de Iguacu
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
Mexico
Hospital Infantil de Mexico Federico Gomez (HIM)
Mexico City, Mexico
Peru
University of San Marcos
Lima, Peru
Sponsors and Collaborators
Investigators
Principal Investigator: Rohan Hazra, M.D. National Cancer Institute (NCI)