Study to evaluate the safety of griffithsin in a carrageenan gel in healthy women
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.
Population Council (2018). Study to evaluate the safety of griffithsin in a carrageenan gel in healthy women (Clinicaltrials.gov Identifier NCT02875119). Retrieved from https://clinicaltrials.gov/ct2/show/NCT02875119
ClinicalTrials.gov Identifier: NCT02875119