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Status:

COMPLETED

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

Lead Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Conditions:

HIV

Eligibility:

All Genders

Up to 21 years

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 A...

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 A...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Static Cohort:
  • Previous participation in a NISDI Protocol
  • Less then 6 years of age (before their 6th birthday) at the time of enrollment into the NISDI Pediatric Protocol
  • HIV-infected
  • HIV infection must be documented in the medical records by:
  • 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
  • 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
  • Documentation of maternal HIV infection by country appropriate National Guidelines
  • 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.
  • Subjects must be able to be followed at a participating clinical site.
  • Subjects may be co-enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV-related effects.
  • Dynamic cohort:
  • HIV-infected less then 6 years of age (before their 6th birthday) at enrollment into this protocol
  • HIV infection documented by:
  • 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
  • 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
  • Documentation of maternal HIV infection by country appropriate National Guidelines
  • 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.
  • Subjects must be able to be followed at a participating clinical site
  • Subjects may be co enrolled in clinical trials for treatment of HIV infection, opportunistic infections, or other HIV related effects
  • EXCLUSION CRITERIA:
  • Children who are born to an HIV infected mother, but are uninfected or of indeterminate HIV infection status
  • Children who are orphans without legal guardians or are wards of the state

Exclusion

    Key Trial Info

    Start Date :

    July 30 2002

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 28 2020

    Estimated Enrollment :

    2129 Patients enrolled

    Trial Details

    Trial ID

    NCT00339612

    Start Date

    July 30 2002

    End Date

    July 28 2020

    Last Update

    July 30 2020

    Active Locations (14)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (14 locations)

    1

    Universidade Federal de Minas Gerais

    Belo Horizonte, Brazil

    2

    Ricardo de Souza STD/HIV Clinic-Caxias do Sul

    Caxias do Sul, Brazil

    3

    Hospital Conceicao

    Porto Alegre, Brazil

    4

    Hospital de Clinicas

    Porto Alegre, Brazil