drugset / Trial / NCT04686279
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
Phase 1
Completed
8 enrolled
University of Pennsylvania
Emory University · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabJohns Hopkins University · collabUniversity of North Carolina, Chapel Hill · collab
NaSingle-groupOpen-labelTreatment
Summary
ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient pre-RAI context
Timeline
- Start
- 2021-04-01
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
Publications
- Bauermeister JA, Arrington-Sanders R, Coleman-Lewis J, Bertagnolli LN, Massih S, Marzinke MA, Fuchs EJ, Zheng R, Anderson T, Addison B, Yang YH, Breakey J, Hoffman J, Bakshi RP, Zak AM, Beselman S, Lin W, Agwu AL, Hightow-Weidman L, Hendrix CW. Safety, Pharmacokinetics, and Acceptability of a Tenofovir Rectal Microbicide Douche Among Young Men Who Have Sex With Men: The DREAM ATN Study (ATN 163). J Infect Dis. 2025 Oct 15;232(4):826-834. doi: 10.1093/infdis/jiaf349.
- Bauermeister JA, Lin W, Webster J, Listerud LL, Burgese T, Agwu A, Lewis JC, Anderson T, Hightow-Weidman L, Hendrix C, Arrington-Sanders R. Assessing the Acceptability of a Tenofovir-Based Rectal Microbicide Douche among Young Men who Have Sex with Men: Results from ATN-DREAM (ATN 163). AIDS Behav. 2025 Oct;29(10):3114-3124. doi: 10.1007/s10461-025-04763-2. Epub 2025 May 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir | Small molecule | 660 mg | Other |