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NCT03976258 · ClinicalTrials.gov registry record
Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV
A clinical trial, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- 190
- Enrollment target
NCT03976258 is a clinical trial that has completed, run by MetroHealth Medical Center. The registered enrollment target is 190 participants.
The verdict
NCT03976258 has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- 190 participants
- Enrollment target
Study Summary
Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who are active intravenous drug users (IVDU); however, this population has been specifically excluded from prior studies assessing immune activation and cardiovascular risk in people living with HIV. In this study, the investigators will specifically target HIV-infected participants who are active IVDU, and co-enroll a control group of HIV-infected participants who never used IV drugs. The investigators will study the specific alterations in immune activation and several mechanisms felt to be potential drivers of immune activation outside of the IVDU population, namely gut integrity alteration, microbial translocation, and oxidized lipids. The investigators will also study the effect of IVDU on markers of arterial inflammation and vascular function. Importantly, the investigators will study the reversibility of immune activation, gut dysfunction, and cardiovascular markers after cessation of IVDU, and to that effect, compare strategies for IVDU cessation-buprenorphine/naloxone versus methadone or vivitrol maintenance treatment.
Interventions
- DRUG Methadone
- DRUG Naltrexone Injection
- DRUG buprenorphine/naloxone
- DRUG Heroin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2022-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03976258
The ClinicalTrials.gov registry entry for NCT03976258 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Methadone is the first listed.
NCT03976258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03976258 about?
NCT03976258 is a clinical study titled "Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV". Despite the advent of safer HIV therapies, high levels of markers of systemic inflammation and increased cardiovascular risk threaten the well-being of individuals living with HIV and present a significant challenge for HIV providers. These risks may be accentuated in HIV-infected individuals who ar...
What is the current status of trial NCT03976258?
This trial is currently completed. The enrollment target is 190 participants. The study started on 2017-07-14. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03976258?
The interventions under investigation include: Methadone (DRUG), Naltrexone Injection (DRUG), buprenorphine/naloxone (DRUG), Heroin (DRUG).
Who is sponsoring clinical trial NCT03976258?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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