The over-arching goal of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is to identify safe, acceptable, feasible and effective interventions that will lead to the end of the HIV epidemic among infants, children, adolescents and pregnant and postpartum women worldwide. To achieve this goal, the Network will evaluate new and longer-lasting treatments for both HIV and tuberculosis (TB) and strategies for antiretroviral treatment (ART)-free remission and address the complications, co-morbidities, and co-infections affecting these populations. The Network?s scientific specific aims are 1) to advance antiretroviral treatment of pregnant and postpartum women with HIV, aiming to optimize maternal and child health outcomes, and to accelerate the evaluation (pharmacokinetics (PK), safety, antiviral efficacy), licensure and optimal use of potent and durable antiretrovirals for pregnant women, infants, children and adolescents with HIV; 2) to evaluate the potential for ART-free remission through therapeutic interventions aimed at prevention, clearance and post-treatment control of HIV reservoirs in infants, children, and adolescents with HIV; 3) to evaluate novel approaches for TB prevention, diagnosis and treatment in pregnant and postpartum women and infants, children and adolescents with and without HIV that will lead to optimal dosing, regimens, licensing and improved treatment outcomes; and 4) to determine optimal and feasible methods for the prevention and management of complications and co-infections of HIV infection and its treatment in infants, children, adolescents and pregnant and postpartum women. The Network will identify and evaluate the most promising and relevant agents and interventions for our populations of interest, based on favorable safety, acceptability, durability and efficacy profiles among non-pregnant adults, for evaluation in phase I-IV clinical research studies, following the sequential drug development model. Strategy studies will also be pursued for targeted interventions and populations. The Network will employ innovative study designs when appropriate to enhance efficiency while maintaining scientific rigor. State-of-the-art socio-behavioral and pharmacometric methods will be integrated into IMPAACT studies to ensure appropriate assessment of factors that may influence outcomes of interest. When appropriate, the Network will pursue early phase evaluation of agents/interventions in infants, children, adolescents and pregnant women in parallel with studies being conducted by other researchers with the same agents/interventions in non-pregnant adults. IMPAACT studies are expected to be conducted at experienced clinical research sites in Africa, Asia, and the Americas. The Network?s research will be developed and conducted with community input at every level and in collaboration with other clinical trials networks, research groups, pharmaceutical industry and other partners. Studies with the highest scientific merit and greatest potential for public health impact will be prioritized for development and implementation.

Public Health Relevance

The overarching research agenda for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network includes four priority areas 1) novel and durable treatment of human immunodeficiency virus (HIV); 2) strategies for antiretroviral treatment-free remission; 3) tuberculosis prevention, diagnosis and treatment; and 4) prevention and management of HIV-associated co-infections and complications. The Network?s research in these areas will focus specifically on pregnant and postpartum women and infants, children and adolescents with and/or affected by HIV, with the ultimate goal of ending the worldwide epidemic in these populations. We will actively engage communities and other research partners to address these scientific and public health priorities.

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 #
2UM1AI068632-15
Application #
9987968
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Miller, Judith A
Project Start
2006-06-29
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Pathology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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
Zhang, Gang; Luk, Brian T; Hamidy, Morcel et al. (2018) Induction of a Na+/K+-ATPase-dependent form of autophagy triggers preferential cell death of human immunodeficiency virus type-1-infected macrophages. Autophagy 14:1359-1375
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
Bender, Jeffrey M; Li, Fan; Adisetiyo, Helty et al. (2018) Quantification of variation and the impact of biomass in targeted 16S rRNA gene sequencing studies. Microbiome 6:155
Abrams, Elaine J; Ananworanich, Jintanat; Archary, Moherndran et al. (2018) Propelling the Pediatric HIV Therapeutic Agenda With Science, Innovation, and Collaboration. J Acquir Immune Defic Syndr 78 Suppl 1:S32-S39
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
Denti, Paolo; Garcia-Prats, Anthony J; Draper, Heather R et al. (2018) Levofloxacin Population Pharmacokinetics in South African Children Treated for Multidrug-Resistant Tuberculosis. Antimicrob Agents Chemother 62:

Showing the most recent 10 out of 303 publications