Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)

PHASE1TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

July 10, 2019

Primary Completion Date

February 4, 2021

Study Completion Date

February 4, 2021

Conditions
HIV Prevention
Interventions
DRUG

Q-Griffithsin (Q-GRFT) enema

Investigational enema composed of 4.2mL Q-Griffithsin (Q-GRFT) 9.6mg/mL combined with approximately 120.8mL of 0.9% sodium chloride solution to yield an active enema study product that will contain and deliver a dose of approximately 40mg of Q-GRFT

OTHER

Placebo enema

Approximately 125mL of 0.9% sodium chloride solution

Trial Locations (1)

15213

HIV/AIDS Clinical Research Unit / University of Pittsburgh, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Intrucept Biomedicine LLC

UNKNOWN

lead

Rhonda Brand

OTHER