Immune Dysfunction in HIV+ Opioid Users
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in the antibody response
研究概览
简要总结
The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people opioid and non opioid users to understand how opioid affect the immune responses (body defenses against infection) to the flu vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Opioid (OP) users/non-users:
- •OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days
- •Opioid never-users in the past year
- •Additional criteria for OP users:
- •OP use for 90 days pre-flu vaccination
- •Continued OP use for 4 weeks post flu vaccination
- •For HIV positive participants:
- •1) HIV infection, as documented by any licensed ELISA kit and confirmed by Western blot at any time prior to study entry. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.
- •Additional criteria for HIV positive participants:
- •On ART for at least 1 year with plasma pending viral load (VL) <200 copies/mL. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment
- •CD4 count available in the prior 6 months and >200/mm3
- •Undetectable viral load (< 200 copies/mL)
- •For HIV negative participants:
- •1) Documented negative HIV test, either by any licensed ELISA or rapid tests within the past 6 months.
- •For all participants:
- •Individuals age 18-60 yrs .
- •No history of other immunodeficiency disorders
- •Not on steroid or other immunosuppressive/immunomodulators medications.
- •No active malignancies.
- •No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
- •Agreeable to receive the influenza vaccination.
- •Agreeable to participate in study for a complete course of study full visits.
- •Able to provide informed consent.
排除标准
- •Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
- •Non-adherence to ART for HIV+
- •Unable to provide informed consent.
- •Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
- •Influenza vaccination already given during the current vaccination season.
研究组 & 干预措施
HIV positive opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
干预措施: Fluzone Quadrivalent (Biological)
HIV positive non-opioid users
Participants will continue their standard of care antiretroviral therapy (ART) and receive flu vaccination as part of the study
干预措施: Fluzone Quadrivalent (Biological)
HIV negative opioid users
Participants will receive flu vaccination as part of the study
干预措施: Fluzone Quadrivalent (Biological)
HIV negative non-opioid users
Participants will receive flu vaccination as part of the study
干预措施: Fluzone Quadrivalent (Biological)
结局指标
主要结局
Change in the antibody response
时间窗: Baseline, 4 weeks, 6 months
Antibody response as measured by the serum vaccine antigen specific hemagglutination inhibition antibody levels.
次要结局
- Immune activation levels(Baseline)
- Circulating T follicular helper cell function(Week 4)
- Circulating T follicular helper cell frequency(Week 4)
- Inflammation biomarker levels(Baseline)
研究者
Savita Pahwa
Professor
University of Miami