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NCT02750540 · ClinicalTrials.gov registry record · Phase 1
Optimization of a Tenofovir Enema for HIV Prevention
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02750540: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT02750540 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02750540, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study 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).
Primary Outcome
Adverse events occurring between dosing and day 7 for each of 3 doses during the study (each will be assessed as a unique dose related event period lasting 7 days) will be assessed according to the following scale: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening
Interventions
- DRUG Tenofovir enema
- OTHER Saline enema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-05 |
| Phase | Phase 1 |
What the finished NCT02750540 record still lists
NCT02750540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Tenofovir enema is the first listed.
NCT02750540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02750540 about?
NCT02750540 is a clinical study titled "Optimization of a Tenofovir Enema for HIV Prevention". 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...
What is the current status of trial NCT02750540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2016-10. Estimated completion is 2019-05.
What interventions are being tested in trial NCT02750540?
The interventions under investigation include: Tenofovir enema (DRUG), Saline enema (OTHER).
Who is sponsoring clinical trial NCT02750540?
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 NCT02750540's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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