Pop Council PC-6500 Vaginal insert

Phase

Objective

We evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of PC-6500 (0.1% GRFT in a carrageenan [CG] gel) in healthy, HIV-negative, non-pregnant women at the Albert Einstein College of Medicine (Bronx, NY).

Prevention Option(s)

Microbicides

Arms and Assigned Interventions

Description

Participants were randomized at baseline (BL) to use 4g of PC-6500 or CG placebo (7:3 ratio) vaginally once daily for 14 days; 5 doses were inserted under clinical observation.

Products

PC-6500

ARMs

Experimental

Results

P05.19LB Griffithsin Administered Vaginally for 14 Days Is Well-tolerated, With Anti-HIV Activity Up to 8 Hours Post Dose in the First-in-human Trial

Official Code

P05.19LB Griffithsin Administered Vaginally for 14 Days Is Well-tolerated, With Anti-HIV Activity Up to 8 Hours Post Dose in the

March 2018

July 2018

Enrollment

Population

Women

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Pop Council PC-6500 Vaginal insert