Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
Status:
Completed
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
This is a two-part study. The first part is a single-dose open label design. The second part
employs a multiple dose, randomized, placebo controlled study design. Studies have
demonstrated that GRFT is highly potent for HIV prevention and is effective at very low
concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal
concentration of GRFT for the prevention of HIV, based on preclinical data, will be
evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be
minimally absorbed systemically, if at all.