Microbicide Trials Network

MTN-026/IPM 038

Details

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: 
Pending

Protocol Chair(s)

Ross Cranston (Protocol Chair)

Description


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.

 

Other Study Info

Sponsors:

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

Co-Sponsors:

IPM

Study Design:

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