International Maternal, Adolescent and Pediatric Therapeutics Clinical Trials Network

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ABSTRACT The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network has significantly advanced efforts to stem the global HIV epidemic among pregnant women, infants, children and adolescents through the conduct of high-quality clinical trials. The IMPAACT vision and overall goal is to end the worldwide HIV epidemic among these vulnerable populations. To achieve this goal, IMPAACT will evaluate novel and durable treatments for both HIV and TB, to establish strategies for antiretroviral treatment (ART)-free remission, and to address the complications, co-morbidities, and co-infections affecting these HIV-infected and at-risk populations of interest. The results of our studies have contributed to licensure or labeling changes for new antiretrovirals/formulations for use in HIV-infected pregnant women, infants and children and influenced international and US guidelines for clinical care in these vulnerable populations. In addition to generating concrete evidence in these areas, IMPAACT's work has served to build much needed research and laboratory capacity in resource-limited settings, where burden of the HIV epidemic remains the greatest. The IMPAACT Laboratory Center has been integral to the Network's success in defining the standards of care for HIV infected pregnant women, children and adolescents. Many of the mechanistic underpinnings that explain the success of IMPAACT clinical trials are managed and discovered by IMPAACT Laboratory Center investigators. In this competitive renewal of the IMPAACT Laboratory Center, we propose a work closely the Operations Center and the Statistical and Data Management Center to develop, implement and evaluate the laboratory activities necessary to accomplish IMPAACT's research agenda. Further, the Laboratory Center will ensure that there are relevant state-of-the-art expertise and technologies and to oversee all laboratory operations confirming that all laboratory results are consistent, reproducible and can support study reconstruction.