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

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ClinicalTrials.gov Identifier: NCT03976258
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Corrilynn Hileman, MetroHealth Medical Center

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
HIV Infection Opioid-use Disorder Cardiovascular Diseases Drug: buprenorphine/naloxone Drug: Methadone Drug: Naltrexone Injection Drug: Heroin

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
HIV-infected adults actively using heroin
HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past.
 Drug: Heroin
This is an observational study. Participants using heroin will be enrolled into this group.
HIV-infected adults never having used heroin
HIV-infected adults on antiretroviral therapy matched to HIV-infected adults actively using heroin by age, sex and CD4+ count.
HIV-infected adults initiating buprenorphine/naloxone
HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone.
 Drug: buprenorphine/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.
HIV-uninfected adults initiating buprenorphine/naloxone
HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with buprenorphine/naloxone.
 Drug: buprenorphine/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.
HIV-infected adults initiating methadone
HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone
 Drug: Methadone
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.
HIV-infected adults initiating Vivitrol
HIV-infected adults on antiretroviral therapy who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol.
 Drug: Naltrexone Injection
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 Name: Vivitrol
HIV-uninfected adults initiating methadone
HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with methadone.
 Drug: Methadone
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.
HIV-uninfected adults initiating Vivitrol
HIV-uninfected adults who are currently using heroin at least 1 month with a cumulative duration of at least 12 months in the past initiating medication assisted treatment (MAT) for opioid use disorder with Vivitrol.
 Drug: Naltrexone Injection
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 Name: Vivitrol


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Plasma, serum, urine, stool, peripheral blood mononuclear cells

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults ages 18 to 80 years with and without HIV infection using heroin or initiating treatment for heroin use or not using heroin.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976258


Contacts
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Contact: Cheryl A Smith, BA 216-778-7141 csmith@metrohealth.org
Contact: Danielle Labbato, RN 216-844-2739 Danielle.Labbato@UHhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Danielle Labbato, RN    216-844-2739    danielle.labbato@UHhospitals.org   
Metrohealth Medical center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Cheryl Smith, BA    216-778-7141    csmith15@metrohealth.org   
Sponsors and Collaborators
MetroHealth Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Corrilynn O Hileman, MD MetroHealth Medical Center
Principal Investigator: Grace A McComsey, MD University Hospitals Cleveland Medical Center
More Information
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Responsible Party: Corrilynn Hileman, Principal Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03976258    
Other Study ID Numbers: IRB17-00336 and IRB17-00429
1R01DA044576-01 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corrilynn Hileman, MetroHealth Medical Center:
heroin
HIV
inflammation
cardiovascular
Additional relevant MeSH terms:
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Cardiovascular Diseases
Naltrexone
Buprenorphine
Methadone
Buprenorphine, Naloxone Drug Combination
Heroin
Naloxone
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents
Antitussive Agents
Respiratory System Agents