Development of Rectal Enema As Microbicide (DREAM)

Investigator: Rada Savic, PhD
Sponsor: Johns Hopkins University

Location(s): United States


A safe, effective HIV pre-exposure prophylaxis strategy with high levels of adherence is urgently needed to protect men and women at highest risk of HIV infection from anal sex, where transmission risk per sex act far exceeds that of cervical-vaginal transmission. We propose development of an enhanced TFV prodrug enema to take advantage of common enema use associated with anal sex and the proven efficacy of TFV. Project 1: Clinical Optimization of a Tenofovir Enema and Adherence Tracking Project Leader: Craig Hendrix DESCRIPTION: The Development of a Rectal Enema As Microbicide (DREAM) Program addresses the critical need to develop a highly effective, safe, and acceptable microbicide enema with the promise of greater adherence as a more behaviorally-transparent alternative for the prevention of rectal HIV infection. The overall goal of the program is to develop a single dose rectal enema to deliver a tenofovir (TFV) prodrug capable of providing one week of protection. This strategy builds upon proven high levels of efficacy of TFV-based pre-exposure prophylaxis (PrEP) in adherent persons and directly targets the greatest weakness of PrEP regimens - prophylactic failure due to poor adherence. Given the common practice of rectal douching with an enema prior to receptive anal sex, we have selected a dosing strategy which requires little or no behavioral change compared to other oral and topical approaches. Topical delivery also significantly reduces systemic exposure compared to oral and injectable approaches.