MTN 033

Principal Investigator(s):Ken Ho, MD
Objective:MTN-033/IPM 044 is a Phase 1, randomized, open label, single-site trial designed to evaluate the pharmacokinetics of dapivirine gel (0.05%) when administered rectally via HTI vaginal applicator and a coital simulation device to healthy, HIV-1 uninfected men and transgender women.  *Study is closed to follow-up*   Last updated May 9, 2021
Prevention Option(s):Microbicides
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionA single dose of study product using an HTI vaginal applicator
Mode of DeliveryGel
DescriptionUp to 10 mLs of gel applied as a rectal lubricant using a coital simulation device
Mode of DeliveryGel
Official Code: NCT03393468
Trial Sponsors: NIAID (DAIDS-ES: 12065), NIH, NIMH
Start Date
End Date
May 2, 2018
October 3, 2018
Age range: 18 Years ↔ any
Population:Cisgender Men