Clinical trial NCT00339612: NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Perinatal
HIV
AIDS
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 2129
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
Secondary outcomes:
measure: HIV RNA copies
timeFrame: q 6 months
measure: CD4 + T cell count
timeFrame: q 6 months
measure: medical history
timeFrame: q 6 months
measure: hematology and chemistry labs
timeFrame: q 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
city: Caxias do Sul
country: Brazil
facility: Ricardo de Souza STD/HIV Clinic-Caxias do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Conceicao
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas
city: Porto Alegre
country: Brazil
facility: Hospital Femina
city: Porto Alegre
country: Brazil
facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Hospital dos Servidores do Estado
city: Rio de Janeiro
country: Brazil
facility: Hospital Geral Nova de Iguacu
city: Rio de Janeiro
country: Brazil
facility: Instituto de Puericultura e Pediatria Martagao Gesteira
city: San Paulo
country: Brazil
facility: Instituto de Infectologica Emilio Ribas (IIER)
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo-Escola Paulista de Medicina
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Falculdade De Medinica
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez (HIM)
city: Lima
country: Peru
facility: University of San Marcos
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Rohan Hazra, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1056/NEJM199811123392001.
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. doi: 10.1001/jama.282.6.531.