Title

Study to evaluate the safety of griffithsin in a carrageenan gel in healthy women

Document Type

Registered Trial

Publication Date

2018

Abstract

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.

DOI

ClinicalTrials.gov Identifier: NCT02875119

Language

English

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