Pop Council PC-6500 Vaginal insert

Status:
Phase:I
Principal Investigator(s):
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
Study Design:
Arms and Assigned Interventions
DescriptionParticipants 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.
Mode of Delivery
ARMsExperimental
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
Start Date
End Date
March 1, 2018
July 2, 2018
Enrollment:15
Age range: ↔ any
Population:Cisgender Women