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Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
NCT04480554 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Inflammation appearing as the primary indexed condition, and to 3 interventions — of which Methadone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04480554 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Pennsylvania, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Inflammation, Opioid-use Disorder, HIV-1-infection, Buprenorphine, Methadone. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04480554?
The interventions under investigation include: Methadone (DRUG), Buprenorphine/naloxone (DRUG), XR-Naltrexone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04480554?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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