Sustained Long Acting Prevention Against HIV Program Operation

Project: Research project

Project Details


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. Yet its implementation remains difficult, as poor adherence has repeatedly confounded clinical progress. Individuals with high risk for HIV infection would benefit from ARV releasing drug delivery systems with long duration and controlled dosing of the drug. Technological achievements in pharmaceutics and medicinal chemistry allow us to envision combining clinically advanced drug delivery technologies and extremely potent and long acting ARV into drug delivery systems that could protect from HIV for many months and perhaps as long as a year. The objective of the Sustained Long-acting Protection from HIV project is to test and clinically develop a long acting drug delivery system of one of the following fourth generation ARV: cabotegravir, rilipivirine, tenofovir alafenamide fumarate, or the tenofovir analog CMX-157. Several parenteral drug delivery systems will be made and tested by three competing teams exploring three unique drug delivery platforms: reservoir implants, degradable implants, and slow release injectables. We will compare our systems functionally for stability, manufacturability, duration, and pharmacokinetic and safety endpoints. We will work in parallel with high-risk groups to develop user based design input and criteria to inform the clinical development of the drug delivery systems. We will also investigate the acceptability of a wide variety of designs in high-risk individuals. A single lead formulation from each drug delivery project will be selected for further study of pharmacokinetics and pharmacodynamics in non-human primates. From these studies a single lead formulation will be selected for clinical development, based on achieving a well-defined target product profile. Next, we will focus on studies required for an investigational new drug applicat
Effective start/end date7/7/156/30/22


  • National Institute of Allergy and Infectious Diseases (5UM1AI120184-05)


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