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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 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 52 participants.
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.
Interventions
- DRUG Truvada
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-04 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02022657
The ClinicalTrials.gov registry entry for NCT02022657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Truvada is the first listed.
NCT02022657 reports 0 study locations.
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.
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