Although antiretroviral therapy (ART) has produced a radical decline in mortality and morbidity from HIV, infections continue to occur at an alarming rate, and treatments fail in an estimated 8% of treatment naïve and 33% of treatment experienced patients within the first year of beginning a new regimen. Currently available ARV formulations necessitate lifelong daily dosing, and suboptimal adherence leads to treatment failure and low rates of protection for PrEP.
An important potential solution to many of the problems associated with life-long ART is the development of long-acting/extended-release (LA/ER) injectable or implantable forms of approved and investigational antiretroviral drugs (ARV’s) that could be given infrequently, either in the clinic or at home. However, there are significant financial and regulatory risks inherent in the development of these formulations, and often the scientists who are developing these compounds outside of industry have insufficient access to the necessary technical expertise, clinical investigators, and community representatives to advance these products. As a consequence, the development of existing and new LA/ER ARV’s is a slow and laborious process and may discourage many from their pursuit.
The purpose of Long-Acting/Extended Release Antiretroviral Resource Program (LEAP) is to support established investigators and encourage new investigators entering this field by 1) providing access to a centralized group of subject matter experts, 2) establishing a communications and data hub for dissemination of important results and resources, and 3) developing a modeling and simulation core to aid investigators in assigning priority to drugs and formulations in development.
|Since tuberculosis is an important co-infection with HIV, LEAP also supports efforts in LA/ER drug discovery for tuberculosis, and mission of the TB Working Group. Learn more about the TB Working Group.|
This portal will serve as a central communications hub/data repository for investigators developing LA/ER ARV’s, serve to facilitate communication amongst investigators and stakeholders, and provide centralized access to data and publications from ongoing laboratory and clinical research as well as available services to move LA/ER development forward for HIV and related infections.
Funded by an R24 grant from the National Institutes of Health, the mission of LEAP is 3-fold:
Paul is accountable for developing and transferring for manufacture better and less expensive chemistries, formulations, and fixed-dose combination products for adults and children; supporting treatment optimization through the development, regulatory filing, and quality assessment of new products, diagnostics, and devices; providing clinical guidance on managing diseases and transitioning to new treatment paradigms;