Current Projects

MTN-035

A randomized, open label cross-over study of three rectal microbicide placebo formulations.

MTN-035 is a multi-site, randomized-sequence, 1:1:1:1:1:1, three-period, open-label crossover study. The study will evaluate the safety, acceptability and tolerability of and adherence to three placebo dosage forms (insert, douche, suppository) when each is applied rectally and used prior to RAI over a 4-week-long period. The study population will consist of healthy, HIV-uninfected men (cisgender and transgender) and transgender women (TGW) who are 18-35 years of age and who report engaging in RAI. Participants will be randomized equally across six application sequences which determine the order each dosage form will be used. Each dosage form will be used for approximately four weeks, and there will be a 1-week washout period between each dosage form application period.

 

It is hypothesized that the placebo rectal insert, the placebo rectal douche, and the placebo rectal suppository will be safe acceptable and tolerable to participants, and that adherence will be high. It is anticipated that this study will take approximately 9-12 months to enroll the target sample size, and each participant will be followed up for approximately 3.5 months. Sites in the US are actively enrolling participants. International sites will be activated in Fall 2019.

Goals

Primary Objectives:

  1. Acceptability and Tolerability

    • To evaluate the acceptability and tolerability of each study product when applied rectally and used prior to RAI

  2. Adherence
    • To evaluate adherence to each study product prior to RAI over a 4-week-long period
  3. Safety

    • To evaluate the safety of each study product when applied rectally and used prior to RAI

Exploratory Objectives:

  1. Relative Acceptability and Tolerability

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

  2. Biomarkers of Mucosal Safety

    • To evaluate the relative acceptability and tolerability between study products when applied rectally and used prior to RAI

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