IMPAACT Leadership Group

About This Grant

PROJECT SUMMARY 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.