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

Cardiovascular Diseases Clinical Trial

Official title:

The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976258
• Other study ID #: IRB17-00336 and IRB17-00429
• Secondary ID: 1R01DA044576-01
• Status: Completed
• Start date: July 14, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• HIV Infection
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

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.
• 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.
• 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.
• Heroin
This is an observational study. Participants using heroin will be enrolled into this group.

Locations

Country	Name	City	State
United States	Metrohealth Medical center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
MetroHealth Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma soluble CD14 concentration	soluble marker of monocyte activation	48 weeks
Primary	Change in Endopat measure of microvascular function	Measure of endothelial function	48 weeks
Primary	Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)	Measure of vascular inflammation	48 weeks
Primary	Change in plasma Interferon Gamma-Induced Protein 10 concentration	soluble marker of inflammation	48 weeks
Primary	Change in plasma intestinal fatty acid binding protein concentration	soluble marker of gut integrity	48 weeks
Secondary	Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry	Measurement of fat stores	48 weeks
Secondary	Change in aortofemoral pulse wave velocity	Measure of arterial stiffness	48 weeks
Secondary	Change is waist to hip ratio	Measurement of central obesity	48 weeks
Secondary	Change in body mass index	Body measurement	48 weeks