The Impact of Intravenous Heroin Use on Immune Activation in Treated HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in plasma soluble CD14 concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active infection, malignancy or other inflammatory condition
- •Uncontrolled diabetes or hypothyroidism
- •Known cardiovascular disease
- •Pregnancy
研究组 & 干预措施
HIV-infected adults actively using heroin
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.
干预措施: Heroin (Drug)
HIV-infected adults initiating 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 buprenorphine/naloxone.
干预措施: buprenorphine/naloxone (Drug)
HIV-uninfected adults initiating 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.
干预措施: buprenorphine/naloxone (Drug)
HIV-infected adults initiating 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 methadone
干预措施: Methadone (Drug)
HIV-infected adults initiating Vivitrol
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.
干预措施: Naltrexone Injection (Drug)
HIV-uninfected adults initiating 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 methadone.
干预措施: Methadone (Drug)
HIV-uninfected adults initiating Vivitrol
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.
干预措施: Naltrexone Injection (Drug)
结局指标
主要结局
Change in plasma soluble CD14 concentration
时间窗: 48 weeks
soluble marker of monocyte activation
Change in plasma Interferon Gamma-Induced Protein 10 concentration
时间窗: 48 weeks
soluble marker of inflammation
Change in plasma intestinal fatty acid binding protein concentration
时间窗: 48 weeks
soluble marker of gut integrity
Change in Endopat measure of microvascular function
时间窗: 48 weeks
Measure of endothelial function
Change in target to background ratio measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET)
时间窗: 48 weeks
Measure of vascular inflammation
次要结局
- Change is waist to hip ratio(48 weeks)
- Change in aortofemoral pulse wave velocity(48 weeks)
- Change in total fat stores measured by Whole body Dual-energy X-ray absorptiometry(48 weeks)
- Change in body mass index(48 weeks)
研究者
Corrilynn Hileman
Principal Investigator
MetroHealth Medical Center