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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 : July 30, 2020
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) )

Tracking Information
First Submitted Date June 19, 2006
First Posted Date June 21, 2006
Last Update Posted Date July 30, 2020
Actual Study Start Date July 30, 2002
Actual Primary Completion Date December 30, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 19, 2019)
  • HIV RNA copies [ Time Frame: q 6 months ]
    characterize complications from both the disease and its treatments
  • CD4 + T cell count [ Time Frame: q 6 months ]
    characterize complications from both the disease and its treatments
  • medical history [ Time Frame: q 6 months ]
    characterize complications from both the disease and its treatments
  • hematology and chemistry labs [ Time Frame: q 6 months ]
    characterize complications from both the disease and its treatments
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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
Intervention Not Provided
Study Groups/Cohorts HIV-infected children who acquired HIV infection through mothe
HIV-infected children in who acquired HIV infection through mother-to-child transmission (MTCT).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2018)
2129
Original Enrollment
 (submitted: June 19, 2006)
2000
Actual Study Completion Date July 28, 2020
Actual Primary Completion Date December 30, 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Mexico,   Peru
Removed Location Countries Argentina,   Jamaica,   United States
 
Administrative Information
NCT Number NCT00339612
Other Study ID Numbers 999902270
02-CH-N270
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators Not Provided
Investigators
Principal Investigator: Rohan Hazra, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 2020