Last Update: 09/14/2006 Printer Friendly Printer Friendly   Email This Page Email This Page  

Domestic and International Pediatric/Perinatal HIV Clinical Studies Network

Domestic and International Pediatric/Perinatal HIV Clinical Studies NetworkThe Pediatric, Adolescent, and Maternal AIDS (PAMA) Branch has funded the multicenter NICHD Pediatric and Perinatal HIV Studies Network and a coordinating center for the Network since 1987. Initially, funding was for the conduct of a single clinical trial to evaluate the use of intravenous immunoglobulin (IVIG) prophylaxis for bacterial infections in HIV-infected children. The Network enrolled 376 children into this trial, which subsequently demonstrated the efficacy of IVIG for this purpose. In 1989-90, the NICHD Network began to collaborate with the Pediatric AIDS Clinical Trials Network (PACTG), which is funded by the National Institute of Allergy and Infectious Diseases, in conducting clinical trials, an effort that has successfully continued to the present.

As the demographics of pediatric and maternal HIV infection have changed over time, the NICHD Network has expanded and modified the number and type of clinical trials sites that form the Network, as well as the types of studies being done within the Network.

In 1991, the PAMA Branch expanded the clinical trials sites to include a specialized obstetric component for performing perinatal trials, and to add an adolescent specialty component. In 1996, the Network underwent a competitive solicitation for new sites, with an emphasis on sites with large pediatric/maternal populations without access to clinical trials by other mechanisms, particularly sites in the southern United States, in which a documented expansion of the HIV epidemic among women existed. In addition, because of increased emphasis on including pathogenesis-based research questions into the conduct of clinical trials, the Network added capabilities for the performance of specialized laboratory testing in the context of clinical trials activities.

The primary goals of the NICHD Domestic and International Pediatric and Perinatal HIV Studies Network include:

  • Evaluating interventions to further reduce mother-to-child HIV transmission, particularly for women who are identified as HIV-infected very late in pregnancy, or at labor, and, therefore, have not received antiretroviral therapy;
  • Evaluating the pharmacokinetics and safety of antiretroviral drugs in pregnant, infected women and their neonates, including metabolic and short- and long-term effects of exposure on the women and their infants;
  • Identifying optimal strategies for timing therapy initiation in antiretroviral-naïve infants, children, and adolescents; determining when to change therapy in those who are antiretroviral-experienced; and finding optimal treatments for those failing therapy;
  • Identifying therapies that improve the clinical status, quality of life, and survival of HIV-infected infants, children, and adolescents at all stages of disease, from early asymptomatic infection to end-stage AIDS, including antiretroviral drugs, therapies aimed at immune reconstitution, and use of therapeutic HIV vaccines;
  • Identifying therapies or prophylactic regimens that prevent or mitigate the development of serious sequelae of pediatric and adolescent HIV infection, including opportunistic infections, growth abnormalities, neurologic/neurodevelopmental impairments, and other complications;
  • Evaluating the long-term impact of antiretroviral therapy on HIV-infected infants, children, and adolescents, including morbidity and survival, with a particular emphasis on metabolic toxicities;
  • Identifying and evaluating gender-specific manifestations of HIV and identifying therapies to treat women-specific manifestations of HIV in infected, non-pregnant women;
  • Evaluating the pathogenesis of HIV disease in children and women, and that of perinatal transmission in the context of clinical trials;
  • Utilizing clinical trials databases maximally, both within the PACTG and from non-PACTG studies, in cross-cutting epidemiologic investigations that focus on significant questions relevant to developing and conducting pediatric/perinatal HIV trials; and
  • Assisting in 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.

For more information, visit https://www.nichdclinicalstudies.org/index.html.