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NCT03060785 · ClinicalTrials.gov registry record · Phase 1
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03060785: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT03060785 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060785, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.
Primary Outcome
Endoscopy will be performed to obtain colorectal tissue biopsies. 15 biopsies will be collected and processed to isolate mucosal mononuclear cells (MMC). TFV-DP will be measured and reported as femtomoles per million cells (fmole/10E6 cells).
Interventions
- DRUG Tenofovir Disoproxil Fumarate/Emtricitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-03-08 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 1 |
What the finished NCT03060785 record still lists
NCT03060785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir Disoproxil Fumarate/Emtricitabine is the first listed.
NCT03060785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03060785 about?
NCT03060785 is a clinical study titled "Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women". This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC) pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy...
What is the current status of trial NCT03060785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-03-08. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT03060785?
The interventions under investigation include: Tenofovir Disoproxil Fumarate/Emtricitabine (DRUG).
Who is sponsoring clinical trial NCT03060785?
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 NCT03060785's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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