This application is a proposal to serve as the Statistical and Data Management Center of the lnternational Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, as part of the IMPAACT Leadership Group (LG). The IMPAACT LG is proposing a research agenda for studies in pediatric and maternal populations to address objectives in the following NIAID high priority research areas: Vaccines of high priority to these populations; cure and/or functional cure of HIV; co-infections, co-morbidities and consequences of antiretroviral therapy; prevention of acquisition of HIV; pharmacology, drug formulate and novel interventions.
Our Specific Aims are: to support the international research agenda of the IMPAACT LG by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who are committed to collaborating with IMPAACT investigators; 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 the IMPAACT LG through innovation in study design and analysis, providing leadership in cross-study analyses, developing efficient methods and systems, and promoting harmonization with collaborating networks.

Public Health Relevance

The expertise provided by the SDMC will help advance research concerning the treatment and prevention of HIV and diseases such as tuberculosis and hepatitis in infants, children, adolescents, and pregnant women. It will achieve this by ensuring that IMPAACT clinical trials and other studies are efficiently designed and analyzed to the highest standards. This research will continue to make significant contributions in advancing optimal HIV treatment and prevention both in the United States and internationally.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI068616-12
Application #
9388943
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Miller, Judith A
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2017-12-01
Budget End
2018-11-30
Support Year
12
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Harvard University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
Koay, Wei Li A; Lindsey, Jane C; Uprety, Priyanka et al. (2018) Intestinal Integrity Biomarkers in Early Antiretroviral-Treated Perinatally HIV-1-Infected Infants. J Infect Dis 218:1085-1089
Angelidou, Konstantia; Palumbo, Paul; Lindsey, Jane et al. (2018) Defining Study Outcomes That Better Reflect Individual Response to Treatment. Pediatr Infect Dis J 37:258-262
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
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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
Adachi, Kristina; Xu, Jiahong; Ank, Bonnie et al. (2018) Congenital CMV and HIV Perinatal Transmission. Pediatr Infect Dis J :
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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