Abstract

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.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01AI068616-04S5
Application #
7991663
Study Section
Special Emphasis Panel (ZAI1-KS-A (J1))
Program Officer
Miller, Judith A
Project Start
2009-11-27
Project End
2012-11-26
Budget Start
2009-11-27
Budget End
2012-11-26
Support Year
4
Fiscal Year
2010
Total Cost
$530,618
Indirect Cost

  Institution

Name
Harvard University
Department
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02115

  Publications

McFarland, Elizabeth J; Karron, Ruth A; Muresan, Petronella et al. (2018) Live-Attenuated Respiratory Syncytial Virus Vaccine Candidate With Deletion of RNA Synthesis Regulatory Protein M2-2 is Highly Immunogenic in Children. J Infect Dis 217:1347-1355
Seddon, J A; Weld, E D; Schaaf, H S et al. (2018) Conducting efficacy trials in children with MDR-TB: what is the rationale and how should they be done? Int J Tuberc Lung Dis 22:24-33
Pinto, Jorge A; Capparelli, Edmund V; Warshaw, Meredith et al. (2018) A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to the WHO Pediatric Weight Band Dosing Guidelines. Pediatr Infect Dis J 37:e29-e35
Momper, Jeremiah D; Best, Brookie M; Wang, Jiajia et al. (2018) Elvitegravir/cobicistat pharmacokinetics in pregnant and postpartum women with HIV. AIDS 32:2507-2516
Hobbs, Charlotte V; Gabriel, Erin E; Kamthunzi, Portia et al. (2018) Prevalence of Asymptomatic Parasitemia and Gametocytemia in HIV-Infected Children on Differing Antiretroviral Therapy. Am J Trop Med Hyg 98:67-70
Weinberg, Adriana; Huang, Sharon; Moscicki, Anna-Barbara et al. (2018) Persistence of memory B-cell and T-cell responses to the quadrivalent HPV vaccine in HIV-infected children. AIDS 32:851-860
Flynn, Patricia M; Taha, Taha E; Cababasay, Mae et al. (2018) Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomi J Acquir Immune Defic Syndr 77:383-392
Patel, Kunjal; Lindsey, Jane; Angelidou, Konstantia et al. (2018) Metabolic effects of initiating lopinavir/ritonavir-based regimens among young children. AIDS 32:2327-2336
Chernoff, Miriam C; Laughton, Barbara; Ratswana, Mmule et al. (2018) Validity of Neuropsychological Testing in Young African Children Affected by HIV. J Pediatr Infect Dis 13:185-201
Kim, S; Seddon, J A; Garcia-Prats, A J et al. (2018) Statistical considerations for pediatric multidrug-resistant tuberculosis efficacy trials. Int J Tuberc Lung Dis 22:34-39

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