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 #
5U01AI068616-05
Application #
7901065
Study Section
Special Emphasis Panel (ZAI1-KS-A (J1))
Program Officer
Miller, Judith A
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2010-06-01
Budget End
2011-05-31
Support Year
5
Fiscal Year
2010
Total Cost
$6,365,182
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

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
Boivin, Michael J; Barlow-Mosha, Linda; Chernoff, Miriam C et al. (2018) Neuropsychological performance in African children with HIV enrolled in a multisite antiretroviral clinical trial. AIDS 32:189-204
Jacobson, Denise L; Lindsey, Jane C; Coull, Brent A et al. (2018) The Association of Fat and Lean Tissue With Whole Body and Spine Bone Mineral Density Is Modified by HIV Status and Sex in Children and Youth. Pediatr Infect Dis J 37:71-77
Itell, Hannah L; McGuire, Erin P; Muresan, Petronella et al. (2018) Development and application of a multiplex assay for the simultaneous measurement of antibody responses elicited by common childhood vaccines. Vaccine 36:5600-5608
Venkatesh, Kartik K; Morrison, Leavitt; Livingston, Elizabeth G et al. (2018) Changing Patterns and Factors Associated With Mode of Delivery Among Pregnant Women With Human Immunodeficiency Virus Infection in the United States. Obstet Gynecol 131:879-890
Rough, Kathryn; Seage 3rd, George R; Williams, Paige L et al. (2018) Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine. N Engl J Med 378:1593-1603
Eke, Ahizechukwu C; Chakhtoura, Nahida; Kashuba, Angela et al. (2018) Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum. J Acquir Immune Defic Syndr 78:308-313
Cranmer, Lisa M; Draper, Heather R; Mandalakas, Anna M et al. (2018) High Incidence of Tuberculosis Infection in HIV-exposed Children Exiting an Isoniazid Preventive Therapy Trial. Pediatr Infect Dis J 37:e254-e256
McGuire, Erin P; Fong, Youyi; Toote, Christopher et al. (2018) HIV-Exposed Infants Vaccinated with an MF59/Recombinant gp120 Vaccine Have Higher-Magnitude Anti-V1V2 IgG Responses than Adults Immunized with the Same Vaccine. J Virol 92:

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