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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. 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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02750540
The ClinicalTrials.gov registry entry for NCT02750540 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tenofovir enema is the first listed.
NCT02750540 reports 0 study locations.
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.
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