The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network will be led by Brooks Jackson, MD, MBA, of Johns Hopkins U, as PI of the Leadership and Operations Center, with Family Health International as the Operations Center. The IMPAACT Statistical and Data Management Center will be headed by David Shapiro, PhD, Harvard U School of Public Health, with Frontier Science & Technology Research Foundation as the Data Management Center. Grace Aldrovandi, MD, U of Southern California will head the IMPAACT Laboratory Center. IMPAACT's mission is to decrease incident HIV and HIV-associated infections including mother-to-child transmission (MTCT) and to decrease mortality/morbidity due to HIV and HIV-associated infections and co-morbidities among infants, children, adolescents, and pregnant/postpartum women worldwide. The above entities will address and support the 5 RFA research priority areas by conducting clinical trials to achieve the following 7 Specific Aims: 1. Evaluate PK, safety, drug interactions of new and existing ARV agents and formulations leading to optimal dosing and licensing for HIV-infected infants, children, adolescents and pregnant women. 2. Evaluate novel approaches for TB prevention, treatment, and diagnosis in HIV-infected children, adolescents, and pregnant women. 3. Develop and test biomedical/behavioral intentions to prevent HIV maternal acquisition and MTCT and to prevent secondary transmission from perinatally HIV-infected adolescents to sexual partners. 4. Evaluate the immunogenicity, safety, and efficacy of vaccines of high priority in HIV-infected pregnant women and their infants, children, and adolescents. 5. Evaluate the potential for HIV cure through therapeutic interventions aimed at prevention and clearance of HIV reservoirs in HIV-infected infants, children and adolescents. 6. Evaluate the PK, safety, and efficacy of new drugs and drug combinations to treat HBV and HCV in HIV infected children, adolescents, and pregnant women. 7. Determine optimal and feasible methods for the prevention and management of co-infections and comorbidities of HIV infection and its treatment.

Public Health Relevance

Many licensed drugs and a number of vaccines for HIV, TB, and hepatitis are not approved for use in pregnant women and children. By conducting clinical trials of new drugs and vaccines in these vulnerable populations, we will determine the safety, dosing, and efficacy of these interventions for the prevention and treatment of HIV and its co-morbidities/co-infections thereby reducing morbidity/mortality worldwide.

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 #
5UM1AI068632-09
Application #
8782599
Study Section
Special Emphasis Panel (ZAI1-BP-A (S1))
Program Officer
Miller, Judith A
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2014-12-01
Budget End
2015-11-30
Support Year
9
Fiscal Year
2015
Total Cost
$24,530,718
Indirect Cost
$588,231
Name
Johns Hopkins University
Department
Pathology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
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Garcia-Prats, Anthony J; Rose, Penelope C; Draper, Heather R et al. (2018) Effect of Coadministration of Lidocaine on the Pain and Pharmacokinetics of Intramuscular Amikacin in Children With Multidrug-Resistant Tuberculosis: A Randomized Crossover Trial. Pediatr Infect Dis J 37:1199-1203
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