drugset / Trial / NCT02750540
Optimization of a Tenofovir Enema for HIV Prevention
Phase 1
Completed
21 enrolled
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID) · collabUniversity of California, Los Angeles · collabUniversity of Pittsburgh · collab
Non-randomizedSingle-groupOpen-labelOther
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).
Timeline
- Start
- 2016-10
- Primary completion
- 2019-05
- Completion
- 2019-05
Publications
- Giguere R, Balan IC, Lentz C, Dolezal C, Carballo-Dieguez A, Fuchs EJ, Anton P, McGowan I, Ho K, Weld E, Hendrix CW. Acceptability of a rectal microbicide douche for HIV prevention: a mixed-methods analysis of a first-in-human formulation pilot study. Sex Transm Infect. 2025 Jan 29;101(1):49-54. doi: 10.1136/sextrans-2024-056209.
- Weld ED, McGowan I, Anton P, Fuchs EJ, Ho K, Carballo-Dieguez A, Rohan LC, Giguere R, Brand R, Edick S, Bakshi RP, Parsons T, Manohar M, Seigel A, Engstrom J, Elliott J, Jacobson C, Bagia C, Wang L, Al-Khouja A, Hartman DJ, Bumpus NN, Spiegel HML, Marzinke MA, Hendrix CW. Tenofovir Douche as HIV Preexposure Prophylaxis for Receptive Anal Intercourse: Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics (DREAM 01). J Infect Dis. 2024 Apr 12;229(4):1131-1140. doi: 10.1093/infdis/jiad535.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tenofovir | Small molecule | 220 mg | Other |
| Comparator | Tenofovir | Small molecule | 660 mg | Other |
Indications
No indication recorded.