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NCT04480554 · ClinicalTrials.gov registry record · Phase 2
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
A Phase 2 study of Opioid Use Disorder and Inflammation, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
- 2
- Study locations
NCT04480554 is a Phase 2 study of Opioid Use Disorder and Inflammation that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 225 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04480554, a Phase 2 study of Opioid Use Disorder and Inflammation, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
- 2
- Study locations
Study Summary
HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut. The overall objective of this study is to define the impact of long-term mu-opiate receptor stimulation or blockage with medication for opiate use disorder (i.e, methadone, buprenorphine/naloxone, or extended-release naltrexone) on the kinetics and extent of immune reconstitution on HIV-1 infected people who inject opiate and initiating antiretroviral therapy.
Conditions Studied
Interventions
- DRUG Methadone
- DRUG Buprenorphine/naloxone
- DRUG XR-Naltrexone
Study Locations (2)
Pennsylvania
- University of Pennsylvania - Philadelphia
Other
- Go Vap Clinic - Ho Chi Minh City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2023-01-30 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04480554
The ClinicalTrials.gov registry entry for NCT04480554 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Methadone is the first listed.
NCT04480554 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT04480554 about?
NCT04480554 is a clinical study titled "Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1". HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut. The overall objective of this study is to define the impact of long-term mu-opiate receptor stimulation or blockage with medicati...
What is the current status of trial NCT04480554?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2023-01-30. Estimated completion is 2025-06-30.
What conditions does trial NCT04480554 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Inflammation, HIV-1-infection, Buprenorphine, Methadone.
What interventions are being tested in trial NCT04480554?
The interventions under investigation include: Methadone (DRUG), Buprenorphine/naloxone (DRUG), XR-Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04480554?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04480554 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.