Past Projects

MTN-033

An open label, randomized Phase 1 study of dapivirine gel administered rectally.

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an applicator or up to 10 mLs of gel applied as a rectal lubricant using a coital simulation device to be inserted and withdrawn rectally for a pre-determined period of time.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

Goals

Primary Objectives:

  1. Pharmacokinetics

    • To characterize the systemic and compartmental pharmacokinetics of dapivirine 0.05% gel applied rectally by two different methods

 

Secondary Objectives:

  1. Safety

    • To assess the safety profile of dapivirine gel administered rectally via HTI vaginal applicator, and with a coital simulation device

  2. Acceptability

    •  To identify product attributes considered likely to challenge and/or facilitate future sustained use of dapivirine 0.05% gel when applied rectally by participants

Exploratory Objectives:

  1. Ex Vivo Efficacy

    • To assess the preliminary (ex vivo) efficacy of dapivirine 0.05% gel formulation

  2. Biomarkers of Mucosal Safety

    • To evaluate the mucosal immunotoxicity of dapivirine 0.05% gel formulation when applied rectally

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