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NCT04870671 · ClinicalTrials.gov registry record · Early Phase 1
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor
A Early Phase 1 study, sponsored by Eastern Virginia Medical School.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
NCT04870671: Completed Early Phase 1 study, sponsored by Eastern Virginia Medical School.
NCT04870671 is a Early Phase 1 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 14 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04870671, a Early Phase 1 study, has completed, sponsored by Eastern Virginia Medical School.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.
Primary Outcome
TFV levels will be measured by the TFV aptasensor and compared to Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) values
Interventions
- DRUG Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2023-01-31 |
| Phase | Early Phase 1 |
What the finished NCT04870671 record still lists
NCT04870671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) is the first listed.
NCT04870671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04870671 about?
NCT04870671 is a clinical study titled "Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor". Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill...
What is the current status of trial NCT04870671?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2021-03-25. Estimated completion is 2023-01-31.
What interventions are being tested in trial NCT04870671?
The interventions under investigation include: Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) (DRUG).
Who is sponsoring clinical trial NCT04870671?
This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04870671's enrollment target sits among peer trials
14 1475th of 2000 higher than 498 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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