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NCT01077310 · ClinicalTrials.gov registry record · NA
Alcohol Pharmacotherapy for HIV+ Prisoners
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01077310: Completed NA study, sponsored by Yale University.
NCT01077310 is a NA study that has completed, run by Yale University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077310, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.
Primary Outcome
Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.
Interventions
- DRUG Placebo
- DRUG Vivitrol- Intramuscular naltrexone (depot-formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT01077310 record still lists
NCT01077310 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01077310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01077310 about?
NCT01077310 is a clinical study titled "Alcohol Pharmacotherapy for HIV+ Prisoners". This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transiti...
What is the current status of trial NCT01077310?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2010-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01077310?
The interventions under investigation include: Placebo (DRUG), Vivitrol- Intramuscular naltrexone (depot-formulation) (DRUG).
Who is sponsoring clinical trial NCT01077310?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01077310's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 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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