Past Projects

MTN-026

A randomized, double blind Phase 1 clinical trial of a dapivirine gel administered rectally.

MTN-026 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 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.

Goals

Primary Objectives:

  1. Safety

    • To evaluate the safety of dapivirine gel formulation when applied rectally.

  2. Pharmacokinetics

    • To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.

 

Secondary Objectives:

  1. Acceptability

    •  To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.

  2. Mucosal Safety

    •  To evaluate the mucosal safety of dapivirine gel when applied rectally.

Exploratory Objectives:

  1. Ex Vivo Efficacy

    • To assess the preliminary (ex vivo) efficacy of dapivirine gel formulation after product is applied rectally.

  2. Pharmacokinetics

    • To characterize the vaginal pharmacokinetics of dapivirine gel following rectal application in women.

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