An observational study in HIV Infection, Opioid-use Disorder and Cardiovascular Diseases, sponsored by MetroHealth Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by MetroHealth Medical Center · Observational
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.
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.
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This study's enrollment of 190 is below the median of 573 across 1,483 observational studies indexed under Cardiovascular Diseases.
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Adults ages 18 to 80 years with and without HIV infection using heroin or initiating treatment for heroin use or not using heroin.
Exclusion Criteria:
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
HIV-infected adults on antiretroviral therapy matched to HIV-infected adults actively using heroin by age, sex and CD4+ count.
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
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
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
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
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
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. Buprenorphine/naloxone 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. 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.
Also known as: Vivitrol
This is an observational study. Participants using heroin will be enrolled into this group.
Change in plasma soluble CD14 concentration
soluble marker of monocyte activation
Time frame: 48 weeks
Change in Endopat measure of microvascular function
Measure of endothelial function
Time frame: 48 weeks
Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)
Measure of vascular inflammation
Time frame: 48 weeks
Change in plasma Interferon Gamma-Induced Protein 10 concentration
soluble marker of inflammation
Time frame: 48 weeks
Change in plasma intestinal fatty acid binding protein concentration
soluble marker of gut integrity
Time frame: 48 weeks
Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry
Measurement of fat stores
Time frame: 48 weeks
Change in aortofemoral pulse wave velocity
Measure of arterial stiffness
Time frame: 48 weeks
Change is waist to hip ratio
Measurement of central obesity
Time frame: 48 weeks
Change in body mass index
Body measurement
Time frame: 48 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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