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
|
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Condition or disease |
---|
HIV |
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 |

- HIV RNA copies [ Time Frame: q 6 months ]
- CD4 + T cell count [ Time Frame: q 6 months ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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

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
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 |
Principal Investigator: | Rohan Hazra, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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 |