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NCT04686279 · ClinicalTrials.gov registry record · Phase 1
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04686279: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT04686279 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04686279, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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
Primary Outcome
Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured the study douche administration, based on the individual participant's sampling schedule, on Day 1 (at 1 hour post dose), Day 2 (24 hours post dose), or Day 4 (72 hours post dose).
Interventions
- DRUG Tenofovir Douche
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 1 |
What the finished NCT04686279 record still lists
NCT04686279 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir Douche is the first listed.
NCT04686279 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04686279 about?
NCT04686279 is a clinical study titled "Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)". 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 d...
What is the current status of trial NCT04686279?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-04-01. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT04686279?
The interventions under investigation include: Tenofovir Douche (DRUG).
Who is sponsoring clinical trial NCT04686279?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04686279's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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