NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
N/A
21 Years
Both
HIV
Trial Information
NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
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.
Inclusion 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
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Rohan Hazra, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
999902270
NCT ID:
NCT00339612
Start Date:
July 2002
Completion Date:
Related Keywords:
- HIV
- AIDS
- Antiretroviral
- Outcomes
- Pediatric
- International
- HIV
Name | Location |
|---|
