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. MTN-033/IPM 044 will enroll a total of approximately 16 evaluable participants ages 18 and older. Participants will be randomized to administer a single dose of study product using an applicator or up to 10 mLs of gel applied as a rectal lubricant using a coital simulation device to be inserted and withdrawn rectally for a pre-determined period of time. Specimens will be collected at multiple time points to assess drug concentrations, ex vivo efficacy, and biomarkers of safety.
MTN-033/IPM 044 is one of the first clinical trials involving the rectal application of dapivirine gel (0.05%) in a cohort of HIV-uninfected adults.
Other Study Info
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
International Partnership for Microbicides (IPM)
Phase I, randomized, open label trial