Microbicide Trials Network

MTN-033

Details

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: 
Pending

Protocol Chair(s)

Ken Ho (Protocol Chair)
Ian McGowan (Protocol Co-Chair)

Description

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an applicator or up to 10 mLs of gel applied as a rectal lubricant using a coital simulation device to be inserted and withdrawn rectally for a pre-determined period of time.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.

 

Other Study Info

Sponsor:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institute of Mental Health

US National Institutes of Health

 

Study Design:

Phase I, randomized, open label trial