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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339612
• Other study ID #: 999902270
• Secondary ID: 02-CH-N270
• Status: Completed
• Start date: July 30, 2002
• Est. completion date: July 28, 2020

Study information

• Verified date: July 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2129
• Est. completion date: July 28, 2020
• Est. primary completion date: December 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

• 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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
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
Mexico	Hospital Infantil de Mexico Federico Gomez (HIM)	Mexico City
Peru	University of San Marcos	Lima

Sponsors (1)

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

Countries where clinical trial is conducted

Brazil,  Mexico,  Peru, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	HIV RNA copies	characterize complications from both the disease and its treatments	q 6 months
Secondary	CD4 + T cell count	characterize complications from both the disease and its treatments	q 6 months
Secondary	medical history	characterize complications from both the disease and its treatments	q 6 months
Secondary	hematology and chemistry labs	characterize complications from both the disease and its treatments	q 6 months