Optimization of a Tenofovir Enema for HIV Prevention (DREAM-01)
Status:Planned
Phase:I
Principal Investigator(s):Johns Hopkins University; University of California, Los Angeles; University of Pittsburgh
Objective: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).
Start Date
End Date
June 4, 2016
June 4, 2017
Enrollment:18
Age range:
18 Years ↔
any
Population:Cisgender Men