Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02573376 · ClinicalTrials.gov registry record · NA
Antiviral Pharmacology and Adherence in Drug Users
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT02573376: Completed NA study, sponsored by University of Colorado, Denver.
NCT02573376 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02573376, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study Summary
Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through prospective pharmacologic and adherence studies in this population. Such studies would be greatly enhanced by an objective, quantitative measure of adherence which does not currently exist in the HCV field. Through the work proposed in this application, sixty HIV/HCV co-infected drug users will be treated with direct acting antiviral agents (DAA) and randomized to receive directly observed DAA therapy (DOT) vs. no directly observed therapy (no-DOT). Patients randomized to no-DOT will have wirelessly observed therapy (WOT) which involves use of a portable medication dispenser that sends a signal to a server with the date and time when the dispenser is opened. In Aim 1, DAA concentrations will be compared in those randomized to DOT vs. no-DOT. DAA pharmacokinetics will also be defined accounting for clinical factors like degree of hepatic impairment and use of concomitant recreational and antiretroviral drugs. The goal is to quantify adherence in this population and the effect of variable adherence on drug concentrations. In Aim 2, DAA concentrations (plasma, cellular, hair) will be linked with adherence patterns identified using WOT and DOT. The goal is to identify a drug concentration biomarker that predicts adherence in this population. In Aim 3, the relationship between DAA adherence (as measured by WOT and DOT and drug concentrations) and rate of cure will be established. The goal is to define the degree of adherence needed for HCV cure.
Interventions
- BEHAVIORAL Directly Observed Therapy
- BEHAVIORAL Wirelessly Observed Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-06 |
| Phase | NA |
What the finished NCT02573376 record still lists
NCT02573376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Directly Observed Therapy is the first listed.
NCT02573376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02573376 about?
NCT02573376 is a clinical study titled "Antiviral Pharmacology and Adherence in Drug Users". Approximately one half of all Americans living with Hepatitis C virus (HCV) are drug users, yet they are the least likely to receive HCV treatment. Drug users are presumed non-adherent and therefore denied potentially life-saving therapy. This assumption can only be confirmed or dispelled through pr...
What is the current status of trial NCT02573376?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2015-11. Estimated completion is 2021-06.
What interventions are being tested in trial NCT02573376?
The interventions under investigation include: Directly Observed Therapy (BEHAVIORAL), Wirelessly Observed Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02573376?
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 NCT02573376's enrollment target sits among peer trials
73 1089th of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03661307 · 73 participants · Phase 1
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
- NCT05386108 · 73 participants · Phase 1
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
- NCT05961592 · 73 participants · Phase 1
R-2487 in Patients With Rheumatoid Arthritis
- NCT06150664 · 73 participants · Phase 1
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia