The concept of preventing sexual transmission of the human immunodeficiency virus (HIV) infection via pre- exposure prophylaxis (PrEP) with antiretroviral drugs (ARV) has been clinically proven. However, its implementation remains a challenge, as poor adherence has repeatedly confounded clinical progress. Individuals at high risk for HIV infection would benefit from ARV drug delivery systems with long duration and sustained/controlled drug release. The objective of the Sustained Long-Acting Protection from HIV (SLAP HIV) program is to develop and clinically test a long-acting drug delivery system of a fourth-generation ARV (cabotegravir or tenofovir alafenamide fumarate).

The SLAP HIV program has three main phases. Initially, the SLAP HIV program supports three teams exploring several parenteral drug delivery platforms: reservoir implants, degradable implants, and controlled release injectables. These systems are compared functionally for stability, manufacturability, duration, pharmacokinetic and safety endpoints. In addition, the program works in parallel with high-risk groups to develop user based design input and criteria to inform the clinical development of the drug delivery systems. Then, the focus of the program is on the preclinical development of the lead product chosen from the developed formulations. This involves conducting the studies required for an investigational new drug application (IND) along with the transfer of manufacturing methods to a contract research organization. Finally, a Phase 1 clinical study concludes the program to examine the safety, pharmacokinetics and acceptability of the lead ARV eluting drug delivery system.

This program brings together 15 basic scientists and clinical investigators from 15 departments across Northwestern University Feinberg School of Medicine, McCormick School of Engineering and Kellogg School of Management. Investigators from Johns Hopkins University, Tulane University, Eastern Virginia Medical School, University of Chicago, University of Utah, Columbia University, Case Western University, University of North Carolina and University of California, Los Angeles also participate in the project.

The impact of the product platforms developed from this research will extend beyond HIV PrEP and will advance our understanding of how to implement long-acting HIV therapy for those already infected, and to other therapeutic areas where long-acting systems are needed.