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NCT02022657 · ClinicalTrials.gov registry record · Phase 1
Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02022657: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT02022657 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02022657, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as Truvada®). With this information, a model will be established to predict adherence rates to TFV-DP using DBS. Forty-eight healthy HIV-uninfected adult participants who are at low risk for HIV infection will be randomized to one of 6 sequences consisting of two directly observed dosing regimens, 33%/67%, 33%/100%, 67%/33%, 67%/100%, 100%/33%, and 100%/67% with each dose regimen lasting approximately 12 weeks, separated by an approximately 12 week washout period. DBS will be collected at regular intervals, including during the washout. The hypothesis of the study is that levels of TFV-DP in DBS will predict adherence rates in the preceding 1-3 months.
Primary Outcome
TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing.
Interventions
- DRUG Truvada
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-04 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
What the finished NCT02022657 record still lists
NCT02022657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which Truvada is the first listed.
NCT02022657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02022657 about?
NCT02022657 is a clinical study titled "Pre-Exposure Prophylaxis (PrEP) Adherence Monitoring Using Dried Blood Spots". The primary objective of this study is to define the mean, variance, and dose proportionality for tenofovir-diphosphate(TFV-DP) in dried blood spots resulting from 33%, 67%, and 100% of daily dosing with 200mg emtricitabine and 300mg of tenofovir disoproxil fumarate (as Truvada®). With this informat...
What is the current status of trial NCT02022657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2014-04. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02022657?
The interventions under investigation include: Truvada (DRUG).
Who is sponsoring clinical trial NCT02022657?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02022657's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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