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NICHD Domestic & International Pediatric & Maternal HIV Clinical Studies Network (NICHD Network)

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Overview

The NICHD Network conducts trials related to preventing and treating HIV infection and its complications in newborns, infants, children, adolescents, and pregnant women. Since 1987, Maternal and Pediatric Infectious Disease Branch (MPIDB) (formerly the Pediatric, Adolescent, and Maternal AIDS Branch) has funded the NICHD Network, currently composed of 25 domestic sites in 13 states and territories and 9 international sites in Latin America, plus a Data Coordinating Center (DCC).

The NICHD Network was established to conduct a single clinical trial evaluating the use of intravenous immunoglobulin (IVIG) prophylaxis for bacterial infections in 376 HIV-infected children. Over time, the NICHD Network has expanded with changes in the demographics of pediatric and maternal HIV infection. The number and type of clinical trial sites in the Network have changed, as well as the types of studies being done.

In 1990, the NICHD Network began collaborating with the National Institute of Allergy and Infectious Diseases (NIAID)-funded Pediatric AIDS Clinical Trials Group (PACTG) to expand clinical trial availability at NICHD clinical trials sites. This collaboration made it possible to conduct clinical trials further evaluating primary antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. This NIAID-NICHD Network collaboration continues today with the NIAID-funded International Pediatric Maternal Adolescent AIDS Clinical Trials (IMPAACT) Group.

The NICHD Network expanded to include sites with more expertise in obstetrics/gynecology and adolescent medicine, as well as international trial sites in Latin America.

As the HIV epidemic has evolved, so has the research addressed by the NICHD Network. In populations of women and children, research gaps related to HIV-associated co-infections such as tuberculosis (TB), hepatitis, and malaria have emerged as HIV research has become increasingly global in nature. As a result, the NICHD Network and NIAID-funded IMPAACT Group broadened their focus to include TB, malaria, hepatitis, and investigation of vaccines to prevent HIV-related or other high-priority infectious diseases in children, adolescents, and pregnant women, in addition to treatment of HIV infection.

In addition to its work with the IMPAACT Group described above, the NICHD Network collaborates with several other networks to design and conduct HIV-related trials. Funded by the NICHD, other NIH Institutes, and other agencies, these networks include (but are not limited to):

The NICHD Network relies on flexible contract mechanisms to initiate timely, high-priority initiatives in response to unanticipated research needs and to conduct planned studies with established protocols.

In addition to a DCC, the NICHD Network uses a centralized specimen repository to store coded biological specimens from NICHD Network studies. This repository serves as a resource for Network and external investigators who are interested in answering specific questions related to HIV/AIDS.

Topic Areas

Current and future areas of research focus include (but are not limited to):

  • Interventions to reduce mother-to-child HIV transmission, with the goal to eliminate perinatal HIV transmission globally;
  • Pharmacokinetics and safety of antiretroviral drugs in pregnant or lactating HIV-infected women and their newborns, including surveillance for:
    • Long-term complications of fetal/infant exposure to drugs used during pregnancy and breastfeeding to prevent perinatal infections and/or treat pregnant and lactating women and
    • Long-term effects on maternal health of antiretroviral drugs used for prevention of transmission;
  • Safety and pharmacokinetics of drugs for the treatment of HIV in infants, children, and adolescents, including those with co-morbidities such as malnutrition, TB, and malaria;
  • Prevention and treatment of HIV-associated infectious/non-infectious morbidity in HIV-infected infants, children, adolescents, and women (pregnant and non-pregnant);
  • Evaluation of vaccines and other biomedical modalities to prevent HIV itself as well as HIV-related and other high-priority infectious diseases;
  • Diagnosis, prevention, and treatment of other high-priority infectious diseases, specifically those that affect infants, children, adolescents, and women (pregnant and non-pregnant) domestically and globally, including the safety and pharmacokinetics of drugs to treat these infections (e.g., TB, malaria, hepatitis);
  • Development and evaluation of strategies to find a cure (or virtual cure) for HIV in infants;
  • Pathogenesis of HIV in infants and children and how it differs from adults within the context of clinical trials; and
  • Development of strategies to prevent HIV acquisition in adolescents and pregnant or lactating women.

The NICHD Network also supports training and infrastructure development at international sites in resource-limited countries to allow future participation in pediatric and perinatal clinical trials conducted within the NICHD Network.

Current Sites

Domestic

  • Boston Medical Center Pediatric HIV Program
  • Children's Diagnostic and Treatment Center (Fort Lauderdale, FL)
  • Children's Hospital of Boston (and Maternity-only Subsite: Brigham and Women's Hospital)
  • Children's Hospital of Los Angeles
  • Children's Hospital of Michigan/Hutzel Hospital
  • Children's National Medical Center (and Maternity-only Subsite: Washington Hospital Center)
  • Harbor—University of California, Los Angeles Medical Center
  • Howard University Hospital
  • Jacobi Medical Center (Bronx, NY)
  • Johns Hopkins University
  • Metropolitan Hospital (New York, NY)
  • Miller Children's Hospital (Long Beach, CA)
  • New York University School of Medicine
  • Rush University/Cook County Hospital
  • San Juan City Hospital
  • State University of New York, Stony Brook
  • Strong Memorial Hospital (Rochester, NY)
  • Tulane University
  • University of Alabama, Birmingham
  • University of California, San Francisco
  • University of Colorado Health Sciences Center
  • University of Florida Health Science Center
  • University of Maryland, Baltimore
  • University of South Florida Children's Hospital
  • University of Southern California Medical Center
  • University of Washington Medical Center

International

Argentina

  • Hospital General de Agudos (Buenos Aires)

Brazil

  • Hospital dos Servidores do Estado (Rio de Janeiro)
  • Hospital Geral de Nova Iguacu
  • Hospital Santa Casa (Porto Alegre)
  • Instituto de Infectologia Emilio Ribas (Sao Paulo)
  • Universidade de Caxias do Sul
  • Universidade de Sao Paulo (Ribeirao Preto)
  • Universidade Federal de Minas Gerais (Belo Horizonte)
  • Universidade Federal de Rio de Janeiro

Westat, Inc., is currently the DCC for the NICHD Network.

More Information

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Last Updated Date: 11/30/2012
Last Reviewed Date: 11/30/2012
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