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

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00339612

Purpose

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
HIV

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:	2500
Study Start Date:	July 2002

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:
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 less than 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:
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339612

Contacts

Contact: Rohan Hazra, M.D.

(301) 435-4627

hazrar@mail.nih.gov

Locations

Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira	Recruiting
Rio de Janeiro, Brazil
Instituto de Infectologica Emilio Ribas (IIER)	Recruiting
San Paulo, Brazil
Hospital dos Servidores do Estado	Recruiting
Rio de Janeiro, Brazil
Sub-Investigator: Maria Leticia Santos Cruz, M.D.
Sub-Investigator: Aluce Loureiro Ouricuri, M.D.
Hospital Conceicao	Recruiting
Porto Alegre, Brazil
Sub-Investigator: Breno Riegel Santos, M.D.
Ricardo de Souza STD/HIV Clinic-Caxias do Sul	Recruiting
Caxias do Sul, Brazil
Hospital das Clinicas da Falculdade de Medinica de Ribeirao	Recruiting
Sao Paulo, Brazil
Universidade Federal de Minas Gerais	Recruiting
Belo Horizonte, Brazil
Hospital Femina	Recruiting
Porto Alegre, Brazil
Sub-Investigator: Rosana Campos da Fonseca, M.D.
Hospital de Clinicas	Recruiting
Porto Alegre, Brazil
Federal University of Sao Paulo-Escola Paulista de Medicina	Recruiting
Sao Paulo, Brazil
Hospital Geral Nova de Iguacu	Recruiting
Rio de Janeiro, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre	Recruiting
Porto Alegre, Brazil
Mexico
Hospital Infantil de Mexico Federico Gomez (HIM)	Recruiting
Mexico City, Mexico
Peru
University of San Marcos	Recruiting
Lima, Peru

Sponsors and Collaborators

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

More Information

Publications:

Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80.

Wade NA, Birkhead GS, Warren BL, Charbonneau TT, French PT, Wang L, Baum JB, Tesoriero JM, Savicki R. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med. 1998 Nov 12;339(20):1409-14.

Lindegren ML, Byers RH Jr, Thomas P, Davis SF, Caldwell B, Rogers M, Gwinn M, Ward JW, Fleming PL. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA. 1999 Aug 11;282(6):531-8.

Study ID Numbers:	999902270, 02-CH-N270
Study First Received:	June 19, 2006
Last Updated:	October 11, 2008
ClinicalTrials.gov Identifier:	NCT00339612
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

AIDS
Antiretroviral
Outcomes
Pediatric

International
HIV
AIDS

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 14, 2009