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Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03976258
Enrollment
190
Registered
2019-06-05
Start date
2017-07-14
Completion date
2022-12-31
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Opioid-use Disorder, Cardiovascular Diseases

Keywords

heroin, HIV, inflammation, cardiovascular

Brief 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.

Detailed description

This is a 48-week matched, prospective, observational, cohort study of HIV-infected adults on antiretroviral therapy who actively use heroin or who have never used heroin. The overarching goals are 1) to define the extent and specifics of immune activation in HIV-infected IV heroin users; 2) to define the effect of IV heroin on gut integrity and permeability, and the relationship of gut integrity alteration and immune activation; 3) importantly, to study the reversibility of immune activation, inflammation, and gut dysfunction after cessation of IV heroin, and to that effect, compare strategies for medication assisted treatment-buprenorphine/naloxone versus methadone or vivitrol maintenance; 4) to study if heightened immune activation associated with active intravenous drug use (IVDU) is associated with higher cardiovascular disease risk, including endothelial dysfunction and arterial inflammation, and if these effects are reversible with buprenorphine/naloxone or methadone.

Interventions

DRUGbuprenorphine/naloxone

This is an observational study. Buprenorphine/naloxone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.

DRUGMethadone

This is an observational study. Methadone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.

This is an observational study. Naltrexone injection for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.

DRUGHeroin

This is an observational study. Participants using heroin will be enrolled into this group.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
MetroHealth Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* HIV infection or no HIV infection * 18 years or older * HIV-1 RNA \< 400 if HIV-infected and on antiretroviral therapy * On stable antiretroviral therapy at least 12 weeks with cumulative duration of at least a year for HIV-infected if on antiretroviral therapy * Currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past for active heroin group * Initiating medication assisted treatment for active heroin use initiating medication assisted treatment groups

Exclusion criteria

* Active infection, malignancy or other inflammatory condition * Uncontrolled diabetes or hypothyroidism * Known cardiovascular disease * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Change in plasma intestinal fatty acid binding protein concentration48 weekssoluble marker of gut integrity
Change in plasma soluble CD14 concentration48 weekssoluble marker of monocyte activation
Change in Endopat measure of microvascular function48 weeksMeasure of endothelial function
Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)48 weeksMeasure of vascular inflammation
Change in plasma Interferon Gamma-Induced Protein 10 concentration48 weekssoluble marker of inflammation

Secondary

MeasureTime frameDescription
Change in aortofemoral pulse wave velocity48 weeksMeasure of arterial stiffness
Change is waist to hip ratio48 weeksMeasurement of central obesity
Change in body mass index48 weeksBody measurement
Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry48 weeksMeasurement of fat stores

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026