This application is a proposal to serve as the Statistical and Data Management Center of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT), in affiliation with the IMPAACT Leadership Group headed by Dr. J. Brooks Jackson (JHU). IMPAACT is proposing a therapeutic research agenda to address objectives in the NIAID high priority research areas of Prevention of Mother-to-Child Transmission of HIV Infection;Translational Research/Drug Development;Optimization of Clinical Management;and Vaccine Research and Development.
The Specific Aims are to support the research agenda of IMPAACT by providing a group of highly experienced statisticians, data managers and other professionals who are knowledgeable in all aspects of HIV therapeutic research and an organizational structure that promotes this work with IMPAACT;to provide expertise and high quality clinical and laboratory data management and communications systems to support the development, conduct, and analysis of IMPAACT studies;and to advance the mission of IMPAACT through innovation in study design and analysis, providing leadership in cross-study analyses and collaborating effectively with other HIV Trials Networks and HIV research organizations.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Study Section
Special Emphasis Panel (ZAI1-KS-A (J1))
Program Officer
Miller, Judith A
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Harvard University
Schools of Public Health
United States
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Mitchell, Charles D; Chernoff, Miriam C; Seage 3rd, George R et al. (2015) Predictors of resolution and persistence of renal laboratory abnormalities in pediatric HIV infection. Pediatr Nephrol 30:153-65
Fouda, Genevieve G; Cunningham, Coleen K; McFarland, Elizabeth J et al. (2015) Infant HIV type 1 gp120 vaccination elicits robust and durable anti-V1V2 immunoglobulin G responses and only rare envelope-specific immunoglobulin A responses. J Infect Dis 211:508-17
Rutstein, Richard M; Samson, Pearl; Fenton, Terry et al. (2015) Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children and adolescents: the Pediatric AIDS Clinical Trials Group Protocol 1020A. Pediatr Infect Dis J 34:162-7
Naranbhai, Vivek; Kim, Soyeon; Fletcher, Helen et al. (2014) The association between the ratio of monocytes:lymphocytes at age 3 months and risk of tuberculosis (TB) in the first two years of life. BMC Med 12:120
Nachman, Sharon; Zheng, Nan; Acosta, Edward P et al. (2014) Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years. Clin Infect Dis 58:413-22
Qin, Min; Brummel, Sean; Singh, Kumud K et al. (2014) Associations of host genetic variants on CD4? lymphocyte count and plasma HIV-1 RNA in antiretroviral naïve children. Pediatr Infect Dis J 33:946-52
Ciaranello, Andrea L; Leroy, Valeriane; Rusibamayila, Asinath et al. (2014) Individualizing the WHO HIV and infant feeding guidelines: optimal breastfeeding duration to maximize infant HIV-free survival. AIDS 28 Suppl 3:S287-99
Watts, D Heather; Stek, Alice; Best, Brookie M et al. (2014) Raltegravir pharmacokinetics during pregnancy. J Acquir Immune Defic Syndr 67:375-81
Lindsey, Jane C; Hughes, Michael D; Violari, Avy et al. (2014) Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission. Pediatr Infect Dis J 33:846-54
Clarke, Diana F; Acosta, Edward P; Rizk, Matthew L et al. (2014) Raltegravir pharmacokinetics in neonates following maternal dosing. J Acquir Immune Defic Syndr 67:310-5

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