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NCT01442311 · ClinicalTrials.gov registry record · NA
Directly Observed Hepatitis C Treatment in Methadone Clinics
A NA study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT01442311: Completed NA study, sponsored by Albert Einstein College of Medicine.
NCT01442311 is a NA study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01442311, a NA study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.
Primary Outcome
Adherence assessed by pill count, self-report, and medical records.
Interventions
- OTHER enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
- OTHER standard DOT (PEG-DOT control arm)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-03 |
| Phase | NA |
What the finished NCT01442311 record still lists
NCT01442311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which enhanced DOT (both pegylated interferon alfa-2a and ribavirin) is the first listed.
NCT01442311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01442311 about?
NCT01442311 is a clinical study titled "Directly Observed Hepatitis C Treatment in Methadone Clinics". Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80%...
What is the current status of trial NCT01442311?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2007-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01442311?
The interventions under investigation include: enhanced DOT (both pegylated interferon alfa-2a and ribavirin) (OTHER), standard DOT (PEG-DOT control arm) (OTHER).
Who is sponsoring clinical trial NCT01442311?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01442311's enrollment target sits among peer trials
80 994th of 2000 higher than 941 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
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