Role of Extended-release Niacin on Immune Activation in HIV-infected Patients Treated With Antiretroviral Therapy: a Proof-of-concept Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Comparison of the change in CD8CD38 percentage during the ER niacin + ART period
研究概览
简要总结
There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels and enable HIV-infected individuals to live longer. However, some participants taking anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS and non-AIDS-related complications.
ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3. Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent scientific research shows that regular consumption of niacin-rich foods may also provide protection against Alzheimer's disease and age-related cognitive decline.
The purpose of this study is to find out:
- If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could reduce T cell immune activation and enhance CD4 recovery;
- If ER niacin can improve your quality of life and your neurocognitive functions
详细描述
Primary objective
• To assess the impact of extended-release niacin (ER niacin) supplementation + antiretroviral therapy (ART) compared to ART alone on T-cell immune activation as defined by CD8CD38 percentage
Secondary objectives
- To assess the change in total CD4 T-cell count after ER niacin administration
- To explore the effect of ER niacin on regulatory T-cells (Th-17/Treg) in blood and gut mucosa samples
- To explore the effect of ER niacin on cytokines and inflammatory markers such as INF-α, IL-1, IL-6, IL-17, D-dimers, usCRP and LPS
- To assess the influence of ER niacin on tryptophan (Trp) plasmatic levels
- To assess changes in cholesterol and triglycerides
- To explore ER niacin tolerance
- To evaluate the impact of ER niacin on quality of life (QoL), fatigue, depression, and neurocognitive scores
Population: All participants will have an undetectable HIV viral load (< 50 copies/mL) for at least 3 months, current CD4 cell count of < 350 cells/µL and be receiving ART for at least the previous 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ER niacin followed by ART alone
For Arm 1, ER niacin administration begins Week 0 and ends Week 24 (defined as 'immediate use' arm).
干预措施: Niacin (Drug)
ART alone followed by ER niacin
For Arm 2, ER niacin administration begins after the Week 24 Visit and ends Week 48 (defined as 'deferred use' arm).
干预措施: Niacin (Drug)
结局指标
主要结局
Comparison of the change in CD8CD38 percentage during the ER niacin + ART period
时间窗: 48 weeks
Comparison of the change in CD8CD38 percentage during the ER niacin + ART period with the change in CD8CD38 during the ART alone period within each arm (Week 0 to Week 24 vs. Week 24 to Week 48 for Arm 1 and Week 24 to Week 48 vs. Week 0 to Week 24 for Arm 2); if the difference between ER niacin versus control is similar in the two time periods, the treatment effect will be pooled adjusting for treatment order
Comparison of the change in CD8CD38 percentage
时间窗: 24 weeks
Comparison of the change in CD8CD38 percentage from Week 0 to Week 24 of Arm 1 (ER niacin + ART) to Week 0 to Week 24 of Arm 2 (ART alone) (ER niacin treatment + ART vs. ART alone for 24 weeks)
次要结局
- Change in plasmatic Trp levels(48 weeks)
- Changes in total cholesterol, HDL, LDL cholesterol and triglycerides(48 weeks)
- Changes in inflammatory markers such as INF-α, IL-1, IL-6, IL-17, usCRP, LPS and D-dimers(48 weeks)
- Change in CD4 cell count and their subsets, including naïve, central memory and effector memory and Th17/Treg cells(48 weeks)
研究者
Dr. Bertrand Lebouche
MD
McGill University Health Centre/Research Institute of the McGill University Health Centre