MTN 037
Status:Ongoing
Phase:I
Principal Investigator(s):Craig Hendrix, MD
Objective:MTN-037 is a Phase 1, open label, sequential dose/volume escalation study designed to evaluate the safety and acceptability of PC-1005 (MIV-150/Zinc Acetate/Carrageenan gel) when administered rectally.
*Study is in follow-up*
Last updated May 8, 2021
Prevention Option(s):Microbicides, MPTs
Study Design:Open label
Arms and Assigned Interventions
DescriptionAll participants will receive 3 single escalating doses of PC-1005 gel during Visits 3, 5, and 7, with a 2-to-6-week washout period between dosing visits. Each participant will be on study for approximately 3 to 5 months.
Mode of DeliveryGel
ARMsExperimental
Official Code:
NCT03408899
Trial Sponsors:
NIAID (DAIDS-ES: 35122)
Start Date
End Date
June 17, 2018
April 19, 2019
Enrollment:13
Age range:
18 Years ↔
any
Population:Cisgender Men, Cisgender Women