Microbicide Research, Development, and Introduction, Round 2: Non-ARV-Based Microbicide

To develop a safe, effective, and acceptable non-ARV-based microbicide that protects users against HIV and also STIs and that can be delivered via different vehicles suitable for provision through public sector programs.

The project includes the following aims: Develop a griffithsin microbicide to be formulated as a sustaineddelivery vaginal ring and an on-demand nanofiber delivery system; Demonstrate the safety and efficacy of the griffithsin formulations against HIV and other STIs in vitro, ex vivo, and in vivo; Identify and follow the regulatory path needed to secure INDs to advance the griffithsin microbicides for clinical testing; and, Plan and conduct a first-in-human Phase 1 clinical study on a griffithsin gel.