MTN 026
Status:Completed
Phase:I
Principal Investigator(s):Ross D. Cranston, MD, FRCP
Objective:MTN-026/IPM 038 is a Phase 1, randomized, double-blind, multi-site, placebo-controlled trial designed to evaluate the safety and acceptability of dapivirine gel (0.05%) when administered rectally to healthy, HIV-1 uninfected men and women. MTN-026 will enroll a total of approximately 27 evaluable participants between the ages of 18 and 45 years (inclusive). Participants will be randomized to receive either a single dose of dapivirine gel (0.05%) or universal HEC placebo gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic. Specimens will be collected at multiple time points to assess drug concentrations, HIV explant infection and mucosal safety.
MTN-026/IPM 038 is the first clinical trial to collect safety and pharmacokinetic data on the rectal application of dapivirine gel (0.05%) in a cohort of HIV-uninfected adults.
Last updated May 15, 2021
Prevention Option(s):Microbicides
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionSingle dose of dapivirine gel (0.05%) rectally followed by 7 daily doses of the same product to be administered under direct observation in the clinic
Mode of DeliveryGel
ARMsExperimental
DescriptionSingle dose of universal HEC placebo rectally followed by 7 daily doses of the same product to be administered under direct observation in the clinic
Mode of DeliveryGel
ARMsPlacebo Comparator
Official Code:
NCT03239483
Trial Sponsors:
NIAID (DAIDS-ES: 12021)
Start Date
End Date
October 26, 2017
September 20, 2018
Enrollment:28
Age range:
18 Years ↔
45 Years
Population:Cisgender Men, Cisgender Women