MTN-033

MTN-033 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 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an applicator or up to 10 mLs of gel applied as a rectal lubricant using a coital simulation device to be inserted and withdrawn rectally for a pre-determined period of time.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 is one of the first clinical trials involving the rectal application of dapivirine gel (0.05%) in a cohort of HIV-uninfected adults.

Protocol Chair(s)
Ho, Ken (Protocol Chair)
Protocol Title
An Open Label Randomized Phase 1 Pharmacokinetic Study of Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults
DAIDS Protocol ID
12065
Status
Enrolling
Formulation
Gel
Drug
Dapivirine
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender women
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institute of Mental Health
US National Institutes of Health
Other Study Info

Phase I, randomized, open label trial


Source URL: http://mtnstopshiv.org/research/studies/mtn-033