MTN-026

MTN-026 was a Phase 1, randomized (2:1), double-blind, multi-site, placebo-controlled trial which evaluated the safety and pharmacokinetics of dapivirine gel (0.05%) when administered rectally to healthy, HIV-1/2 uninfected men and women. MTN-026 enrolled a total of 27 evaluable participants between the ages of 18 and 45 years (inclusive). Participants were randomized to receive either a single dose of dapivirine gel (0.05%) or universal HEC placebo gel rectally, followed by seven daily doses of the same product administered under direct observation in the clinic. Specimens were collected at multiple time points to assess drug concentrations, HIV explant infection and mucosal safety.

MTN-026 was 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. The study completed follow-up on September 20, 2018. Primary results were presented at the Research for Prevention (HIVR4P) conference held virtually on January 27-28 and February 3-4, 2021. The primary manuscript is under review at AIDS Research and Human Retroviruses.

Protocol Chair(s)
Cranston, Ross (Protocol Chair)
Protocol Title
A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
DAIDS Protocol ID
12021
Status
Closed to Follow Up
Formulation
Gel
Drug
Dapivirine
Placebo
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
Thailand
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender men
Transgender women
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Sponsor(s)
DAIDS
Other Study Info

Phase I, multi-site, two-arm, randomized (2:1), double-blind, placebo-controlled trial


Source URL: https://www.mtnstopshiv.org/research/studies/mtn-026