Optimization of a Tenofovir Enema for HIV Prevention
Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
DREAM-01 is an early phase 1, open label, dose-escalation and variable osmolarity study to
compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3
formulations of a tenofovir (TFV) enema. The goal of the study is to identify the dose and
osmolarity of a TFV enema for human immunodeficiency virus (HIV) pre-exposure prophylaxis
(PrEP) which achieves the desired colonic mucosal mononuclear cells (MMC) tenofovir
diphosphate (TFV-DP) target concentrations that have previously been shown to confer
protection from HIV acquisition in men who have sex with men (MSM).
Phase:
Phase 1
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
University of California, Los Angeles University of Pittsburgh