Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of bio-marker pathways that are abnormal.
研究概览
简要总结
Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, [including substance use and frequency], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline.
详细描述
The long-term goal for the proposed research is to apply a systems biology approach to discover evidence that provides the basis for understanding the complex and at times conflicting roles for marijuana in chronic inflammation in HIV-infected youth. To achieve the goal, a systems biology approach with two aims is designed:
Aim 1. To identify inflammatory immune pathways perturbed by recreational marijuana with or without concomitant use of tobacco products by applying a deep sequencing approach to define global transcriptome of peripheral blood cells from HIV-infected virally suppressed youth.
Aim 2. To develop biomarker profiles associated with pro- or anti-inflammatory pathways perturbed by marijuana and to discover biomarker profiles linked to neurocognitive impairment that are impacted by marijuana and tobacco use by YWH
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
- 21 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years 0 days - less than28 years 364 days
- •Currently treated with stable ART and no ART changes for >6months.
- •Willingness to participate in CASI questionnaire of self-reported substance use
- •Documented behavioral transmission of HIV infection based on CLIA approved HIV antibody/antigen based testing method in medical record -HIV diagnosis greater than or equal to years. Viral load LESS THAN 50 COPIES/ML for the past 6 months. --
- •Patients may have had single blips in viral load to greater than 50 but less than 1000 copies/ml within the year prior to screening.
- •Current Substance profile by chart review or phone screening:
- •Marijuana use defined as marijuana use by any route at least 3 times per week in the absence of tobacco. N=
- •Tobacco use only based on report of regular (at least 3 times per week smoking). N=24
- •Tobacco plus marijuana use defined as regular smoking and marijuana (at least 3 times per week) N =7
- •No substance use of any type (alcohol, tobacco, marijuana or other recreational drugs in the past 90 days). N = 10
- •Able to provide written informed consent in English and to adhere to protocol schedule
排除标准
- •History of AIDS defining illness
- •Pregnancy at any time during the study
- •Use of substances that would interfere with the ability to complete the study
- •History of significant cognitive or motor impairment or other chronic condition that would interfere with the ability to complete the study and impact neurocognitive testing
- •Acute psychiatric symptoms (e.g. suicidality, mania, psychosis or severe depression)
- •Other neurological disorder (e.g. multiple sclerosis, seizure disorder, etc.) requiring ongoing treatment or active outpatient evaluation
- •Severe mental illness (requiring antipsychotic or mood stabilizing medications and/or inpatient hospitalization in past year)
- •History of CNS infection (AIDS opportunistic (e.g. toxoplasmosis) or non-opportunistic (bacterial meningitis) with lasting or permanent neurological sequelae)
- •Underlying and/or uncontrolled medical illnesses that may result in chronic inflammation , (e.g. SLE or autoimmune disease) as determined by the PI
- •Nursing mothers
- •Unable to read and write in English
结局指标
主要结局
Number of bio-marker pathways that are abnormal.
时间窗: 24 months
This is measured by molecular mechanism of chronic macrophage activation.
Plasma levels of sCD163
时间窗: 24 months
Chi-square test will be used to compare discrete variables
Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)
时间窗: 24 months
Neurocognitive function as measured by Grooved Pegboard test
时间窗: 24 months
Neurocognitive function as measured by Timed Gait Test
时间窗: 24 months
Neurocognitive function as measured by Beck Depression Inventory-II
时间窗: 24 months
Neurocognitive function as measured by Base ATN Adherence Questions
时间窗: 24 months
Neurocognitive function as measured by Trial Making Test (TMT)
时间窗: 24 months
Neurocognitive function as measured by the WRAT-4 Word Reading subtest
时间窗: 24 months
Neurocognitive function as measured by Hopkins Verbal Learning Test-R
时间窗: 24 months
Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning
时间窗: 24 months
Neurocognitive function as measured by the Brief Visuospatial Memory Test-R
时间窗: 24 months
Neurocognitive function as measured by Activities of Daily Living Questionnaire
时间窗: 24 months
Neurocognitive function as measured by Brief Symptom Inventory
时间窗: 24 months
Neurocognitive function as measured by ASSIST (substance abuse)
时间窗: 24 months
Neurocognitive function as measured by Verbal Fluency Test
时间窗: 24 Months
次要结局
未报告次要终点