NCT03976258

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
• Phase: —
• Study type: Observational
• Enrollment: 190 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infection
• Opioid-use Disorder
• Cardiovascular Diseases

Interventions

Type	Name	Description
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.
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.
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.
DRUG	Heroin	This is an observational study. Participants using heroin will be enrolled into this group.

Timeline

• Start date: 2017-07-14
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-06-05
• Last updated: 2023-10-02

Locations

2 sites across 1 country: United States