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 with Complex Structure Cooperative Agreement (UM1)
Project #
3UM1AI068616-07S1
Application #
8645807
Study Section
Special Emphasis Panel (ZAI1-KS-A (J1))
Program Officer
Miller, Judith A
Project Start
2006-06-29
Project End
2013-12-31
Budget Start
2013-06-01
Budget End
2013-12-31
Support Year
7
Fiscal Year
2013
Total Cost
$3,505,351
Indirect Cost
$766,785

  Institution

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

  Publications

Walters, Elisabetta; Scott, Lesley; Nabeta, Pamela et al. (2018) Molecular Detection of Mycobacterium tuberculosis from Stools in Young Children by Use of a Novel Centrifugation-Free Processing Method. J Clin Microbiol 56:
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:
Yeganeh, Nava; Watts, D Heather; Xu, Jiahong et al. (2018) Infectious Morbidity, Mortality and Nutrition in HIV-exposed, Uninfected, Formula-fed Infants: Results From the HPTN 040/PACTG 1043 Trial. Pediatr Infect Dis J 37:1271-1278
Chernoff, Miriam; Angelidou, Konstantia Nadia; Williams, Paige L et al. (2018) Assessing Psychiatric Symptoms in Youth Affected by HIV: Comparing a Brief Self-Administered Rating Scale with a Structured Diagnostic Interview. J Clin Psychol Med Settings 25:420-428
Walters, Elisabetta; van der Zalm, Marieke M; Demers, Anne-Marie et al. (2018) Specimen Pooling as a Diagnostic Strategy for Microbiologic Confirmation in Children With Intrathoracic Tuberculosis. Pediatr Infect Dis J :
Eke, Ahizechukwu C; McCormack, Shelley A; Best, Brookie M et al. (2018) Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum. J Clin Pharmacol :
Ruiseñor-Escudero, Horacio; Familiar, Itziar; Nyakato, Mary et al. (2018) Building capacity in neurodevelopment assessment of children in sub-Saharan Africa: A quality assurance model to implement standardized neurodevelopment testing. Child Neuropsychol :1-16
Mulligan, Nikki; Best, Brookie M; Wang, Jiajia et al. (2018) Dolutegravir pharmacokinetics in pregnant and postpartum women living with HIV. AIDS 32:729-737
Svensson, Elin M; du Bois, Jeannine; Kitshoff, Rene et al. (2018) Relative bioavailability of bedaquiline tablets suspended in water: Implications for dosing in children. Br J Clin Pharmacol :
Nachman, Sharon; Alvero, Carmelita; Teppler, Hedy et al. (2018) Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial. Lancet HIV 5:e715-e722

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