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

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.

Conditions

• HIV Infection
• Opioid-use Disorder
• Cardiovascular Diseases

Interventions

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• MetroHealth Medical Center

  lead OTHER

Principal Investigators

• Corrilynn O Hileman, MD · MetroHealth Medical Center

• Grace A McComsey, MD · University Hospitals Cleveland Medical Center

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-14

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• United States

Study Locations