drugset / Trial / NCT04016233
Tenofovir Rectal Douche to Prevent HIV Transmission
Phase 1
Completed
9 enrolled
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID) · collabUniversity of Pittsburgh · collab
NaSingle-groupOpen-labelPrevention
Summary
DREAM-03 is an early phase-1, open label study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 sequences of tenofovir (TFV) and non-medicated douches. 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
- 2020-01-10
- Primary completion
- 2021-04-27
- Completion
- 2021-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir | Small molecule | 660 mg | Rectal |