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

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ClinicalTrials.gov Identifier: NCT00339612
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV

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 Design
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Study Type : Observational
Actual Enrollment : 2129 participants
Observational Model: Cohort
Time Perspective: Other
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
Study Start Date : July 30, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Secondary Outcome Measures :
  1. HIV RNA copies [ Time Frame: q 6 months ]
  2. CD4 + T cell count [ Time Frame: q 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Hospital Femina
Porto Alegre, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, Brazil
Hospital Geral Nova de Iguacu
Rio de Janeiro, Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira
Rio de Janeiro, Brazil
Instituto de Infectologica Emilio Ribas (IIER)
San Paulo, Brazil
Federal University of Sao Paulo-Escola Paulista de Medicina
Sao Paulo, Brazil
Hospital das Clinicas da Falculdade De Medinica
Sao Paulo, Brazil
Mexico
Hospital Infantil de Mexico Federico Gomez (HIM)
Mexico City, Mexico
Peru
University of San Marcos
Lima, Peru
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Rohan Hazra, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00339612     History of Changes
Other Study ID Numbers: 999902270
02-CH-N270
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: July 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Perinatal
HIV
AIDS