Hydrogel Injectable Depot System for Next-Generation Long-Acting HIV Prevention and Contraception: Project Horizon
The objective of Project Horizon, funded by NIH/NIAID, is to develop preclinically a systemic, long-acting, multipurpose prevention technology (MPT) incorporating both effective contraceptive and HIV prevention agents, while integrating characteristics preferred by target end-users in a US cohort.
Under an initial R61 phase, a first generation long-acting MPT injectable hydrogel depot was developed using dolutegravir, an HIV integrase inhibitor and levonorgestrel, a potent hormonal contraceptive. Under the ongoing R33 phase of Project Horizon, a more clinically relevant depot formulation, designed for co-delivery of levonorgestrel with the clinically proven, integrase inhibitor cabotegravir, has been selected for continued development. Activities supporting this development include:
- Preclinical proof-of-concept of a combination cabotegravir/levonorgestrel depot providing 3 months dual protection of HIV and pregnancy from low-volume subcutaneous injection
- Evaluation of user preferences for long acting MPT injectable product attributes through formative research and discrete choice experiment in US populations
- Initial engagement with the US FDA on the clinical development and regulatory strategy for a first-in-class long-acting MPT injectable delivery two proven drugs for HIV prevention and contraception
- This product is being developed with support leveraged from multiple awards, including Project MATRIX: A USAID Project to Advance the Research and Development of Innovative HIV Prevention Products for Women
Research reported on this webpage was supported by the National Institutes of Health under award number R33AI142685.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.