NICHD INTERNATIONAL & DOMESTIC PEDIATRIC & MATERNAL HIV STUDIES COORDINATING CTR

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The Pediatric, Domestic, and Maternal AIDS (PAMA) Branch of the Center for Research for Mothers and Children (CRMC) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a need for a Data Coordinating Center to continue the current activities of development, implementation, and direction of a wide range of domestic and international research activities for the study of epidemiology, clinical manifestations, pathogenesis, transmission, treatment, and prevention of HIV infection and its infectious and noninfectious complications in infants, children, adolescents, and women (pregnant and non-pregnant). The Contractor will furnish all the necessary services, qualified personnel, materials, equipment, and facilities needed to implement, maintain, coordinate, and manage a multi-site network of clinical centers to conduct current and future clinical trials of the preceding referenced research. The Data Coordinating Center will facilitate the research for the evaluation of investigational therapies, diagnostic techniques, prevention strategies, epidemiology and natural history of multiple aspects of HIV infection and disease and other high priority infections in pediatric, adolescent, and maternal patient populations, in addition to those tasks outlined elsewhere in the Statement of Work for the base contract and its separate options. This contract is for the Data Coordinating Center for domestic and international AID Network clinical trials for the Maternal and Pediatric Infectious Disease Branch (MPIDB) (formerly the Pediatric, Adolescent, and Maternal AIDS Branch). 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, 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): ¿ Adult AIDS Clinical Trials Group ¿ Adolescent Medicine Trials Network for HIV/AIDS Interventions ¿ Pediatric European Network for Treatment of AIDS (PENTA) ¿ Centers for Disease Control and Prevention Tuberculosis Trials Consortium 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.