CBD-induced Biomarkers of Inflammation Reduction in People Living With HIV at the Single Cell Level
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Differentially Expressed Genes
研究概览
简要总结
People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH.
The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to take CBD and to participate in follow up for two months
- •Older than 21 and younger than 60
- •Under antiretroviral therapy for 5+ years and suppressed viral load (CD4 count <350cells/ml)
排除标准
- •Conditions/medications that may impair the immune response, e.g., rheumatoid arthritis, cancer, diabetes, chronic infections, CAD (Cold agglutinin disease), cellulitis, autoimmune diseases such as lupus, sarcoidosis
- •All medications that may affect inflammation such as aspirin, steroids, statins; CD4 count <350cells/ml), pregnancy, and current marijuana or CBD use (urine drug screen)
- •UF(University of Florida)/Shands staff and students will not be considered for enrollment
研究组 & 干预措施
CBD Intervention
Participants will self-administer CBD daily for 2 months.
干预措施: CBD oil (Drug)
结局指标
主要结局
Number of Differentially Expressed Genes
时间窗: Two time points considered: baseline, and after 1 month (1 individual) or 2 months (2 individuals)
Number of genes with a significant fold change before/after CBD in PBMCs (Peripheral Blood Mononuclear Cells) related to inflammation genes, calculated before and after CBD treatment (baseline and 1 month for 1 participant, 2 months for 2 participants).
次要结局
未报告次要终点