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NCT02012621 · ClinicalTrials.gov registry record
Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 807
- Enrollment target
NCT02012621: Completed study, sponsored by University of Colorado, Denver.
NCT02012621 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 807 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02012621 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 807 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a TFV-based regimen. Using DBS will allow the investigators to assess this simple method to measure drug exposure in the clinical setting. The investigators hypothesize that TFV-DP levels will be lowest in individuals with a detectable viral load and highest in those with viral suppression.
Primary Outcome
HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); reference group: drug concentration (TFV-DP) \< 350 femtomole (fmol)/punch vs. drug concentration (TFV-DP) \>= 1850 fmol/punch; adjusted odds ratio calculated using generalized estimating equations; concentration cutoffs established in prior research of healthy volunteers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 807 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-07 |
What the finished NCT02012621 record still lists
NCT02012621 is an observational study that tracks outcomes without assigning an intervention. The registered 807 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02012621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02012621 about?
NCT02012621 is a clinical study titled "Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy". The purpose of this study is to evaluate cumulative exposure to tenofovir diphosphate (TFV-DP) using dried blood spots (DBS) in treated HIV-infected patients who are receiving a TFV-based regimen. Using DBS will allow the investigators to assess this simple method to measure drug exposure in the cli...
What is the current status of trial NCT02012621?
This trial is currently completed. The enrollment target is 807 participants. The study started on 2013-12. Estimated completion is 2017-07.
Who is sponsoring clinical trial NCT02012621?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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