DREAM-01

Status:Ongoing
Phase:I
Principal Investigator(s):
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.    Last updated May 3, 2021
Prevention Option(s):Microbicides, MPTs
Study Design:Non-randomized, Open label
Official Code: NCT02750540
Trial Sponsors: NIAID (DAIDS-ES: 12067)
Start Date
End Date
October 5, 2016
May 1, 2019
Enrollment:21
Age range: 18 Years ↔ any
Population:Cisgender Men