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NCT04195776 · ClinicalTrials.gov registry record · Phase 1
Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04195776: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT04195776 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195776, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
DREAM-02 is a phase 1, open label study to evaluate different sequences of tap water douching and simulated receptive anal intercourse (sRAI) in the presence of a tenofovir douche designed to confer protection from Human Immunodeficiency Virus (HIV) acquisition. DREAM-02 will assess the safety and pharmacokinetics (PK) of different sequences of administration of tap water (H2O) and rectal tenofovir (TFV) douches to more accurately represent the community practice of commonly using cleansing douches prior to RAI, and occasionally after RAI. DREAM-02 results are essential to gain understanding of Tenofovir diphosphate (TFV-DP) concentrations at various anatomic distances in the colon, and how those concentrations may be modified by sRAI, seminal fluid, and sequence of cleansing tap water douches.
Primary Outcome
Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured 3 hours after each study douche sequence administration.
Interventions
- DRUG Tenofovir Douche
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 1 |
What the finished NCT04195776 record still lists
NCT04195776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir Douche is the first listed.
NCT04195776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04195776 about?
NCT04195776 is a clinical study titled "Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse". DREAM-02 is a phase 1, open label study to evaluate different sequences of tap water douching and simulated receptive anal intercourse (sRAI) in the presence of a tenofovir douche designed to confer protection from Human Immunodeficiency Virus (HIV) acquisition. DREAM-02 will assess the safety and p...
What is the current status of trial NCT04195776?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-06-01. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT04195776?
The interventions under investigation include: Tenofovir Douche (DRUG).
Who is sponsoring clinical trial NCT04195776?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04195776's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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