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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
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Single 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 Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Description
Single 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 Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Trial Sponsors
NIAID (DAIDS-ES: 12021)
October 2017
September 2018
Enrollment
28
18
Years
45
Years
Population
Men
Women
Sites

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

Silom Community Clinic

Bangkok
Thailand

University of Pittsburgh CRS

Pittsburgh, Pennsylvania
United States of America