NCT00339612

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,129

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2002

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2011

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

9.4 years

First QC Date

June 19, 2006

Last Update Submit

July 28, 2020

Conditions

HIV

Keywords

PerinatalHIVAIDS

Outcome Measures

Secondary Outcomes (4)

  • HIV RNA copies

    q 6 months

  • CD4 + T cell count

    q 6 months

  • medical history

    q 6 months

  • hematology and chemistry labs

    q 6 months

Study Arms (1)

HIV-infected children who acquired HIV infection through mothe

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

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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:
  • 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
  • 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
  • +23 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Universidade Federal de Minas Gerais

Belo Horizonte, Brazil

Location

Ricardo de Souza STD/HIV Clinic-Caxias do Sul

Caxias do Sul, Brazil

Location

Hospital Conceicao

Porto Alegre, Brazil

Location

Hospital de Clinicas

Porto Alegre, Brazil

Location

Hospital Femina

Porto Alegre, Brazil

Location

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil

Location

Hospital dos Servidores do Estado

Rio de Janeiro, Brazil

Location

Hospital Geral Nova de Iguacu

Rio de Janeiro, Brazil

Location

Instituto de Puericultura e Pediatria Martagao Gesteira

Rio de Janeiro, Brazil

Location

Federal University of Sao Paulo-Escola Paulista de Medicina

São Paulo, Brazil

Location

Hospital das Clinicas da Falculdade De Medinica

São Paulo, Brazil

Location

Instituto de Infectologica Emilio Ribas (IIER)

São Paulo, Brazil

Location

Hospital Infantil de Mexico Federico Gomez (HIM)

Mexico City, Mexico

Location

University of San Marcos

Lima, Peru

Location

Related 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. doi: 10.1056/NEJM199411033311801.

    PMID: 7935654BACKGROUND

  • 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.

    PMID: 9811915BACKGROUND

  • 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.

    PMID: 10450714BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Rohan Hazra, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

July 30, 2002

Primary Completion

December 30, 2011

Study Completion

July 28, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

BR(12)ME(1)PE(1)