Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV
Condition: HIV Infection; Opioid-use Disorder; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Opioid-Related Disorders
Study type: Observational

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.
    

Intervention name(s): buprenorphine/naloxone; Methadone; Naltrexone Injection; Heroin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.; This is an observational study. Participants using heroin will be enrolled into this group.
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone; Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Heroin; Naloxone
Observational model: Cohort
Time perspective: Prospective
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.
      
Biospecimen description: 
      Plasma, serum, urine, stool, peripheral blood mononuclear cells
    
Keywords: heroin; HIV; inflammation; cardiovascular