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Completed

NCT Number: NCT03976258

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 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine/naloxone

Drug

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.

Methadone

Drug

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.

Naltrexone Injection

Drug

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.

Other names: Vivitrol

Heroin

Drug

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

Primary outcomes

  1. Change in plasma soluble CD14 concentration

    Time frame: 48 weeks

    soluble marker of monocyte activation

  2. Change in Endopat measure of microvascular function

    Time frame: 48 weeks

    Measure of endothelial function

  3. Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)

    Time frame: 48 weeks

    Measure of vascular inflammation

  4. Change in plasma Interferon Gamma-Induced Protein 10 concentration

    Time frame: 48 weeks

    soluble marker of inflammation

  5. Change in plasma intestinal fatty acid binding protein concentration

    Time frame: 48 weeks

    soluble marker of gut integrity

Secondary outcomes

  1. Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry

    Time frame: 48 weeks

    Measurement of fat stores

  2. Change in aortofemoral pulse wave velocity

    Time frame: 48 weeks

    Measure of arterial stiffness

  3. Change is waist to hip ratio

    Time frame: 48 weeks

    Measurement of central obesity

  4. Change in body mass index

    Time frame: 48 weeks

    Body measurement

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 5, 2019
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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