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

NCT ID: NCT00339612

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-07-30
• Study Completion Date: 2020-07-28

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.

Conditions

HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV-infected children who acquired HIV infection through mothe

HIV-infected children in who acquired HIV infection through mother-to-child transmission (MTCT).

No interventions assigned to this group

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rohan Hazra, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Federal University of Sao Paulo-Escola Paulista de Medicina

São Paulo, , Brazil

Hospital das Clinicas da Falculdade De Medinica

São Paulo, , Brazil

Instituto de Infectologica Emilio Ribas (IIER)

São Paulo, , Brazil

Hospital Infantil de Mexico Federico Gomez (HIM)

Mexico City, , Mexico

University of San Marcos

Lima, , Peru

Countries

Brazil; Mexico; Peru

References

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. doi: 10.1056/NEJM199411033311801.

Reference Type: BACKGROUND

PMID: 7935654 (View on PubMed)

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. doi: 10.1056/NEJM199811123392001.

Reference Type: BACKGROUND

PMID: 9811915 (View on PubMed)

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. doi: 10.1001/jama.282.6.531.

Reference Type: BACKGROUND

PMID: 10450714 (View on PubMed)

Other Identifiers

02-CH-N270

Identifier Type: -

Identifier Source: secondary_id

999902270

Identifier Type: -

Identifier Source: org_study_id