Proof-of-Concept Study: Investigating the Impact of NMN Supplementation on CD4+ T Cell Recovery in Virologically Suppressed HIV Patients With Immunological Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7
- 主要终点
- Primary Outcome
研究概览
简要总结
This proof-of-concept study aims to investigate the potential impact of supplementing with Nicotinamide Mononucleotide (NMN), a direct precursor of NAD+ on CD4+ T cell recovery in virologically suppressed HIV patients experiencing immunological failure on ART. We hypothesize that NMN supplementation will increase intracellular NAD+ levels, thereby improving CD4+ T cell function and potentially reversing immunological failure. A small cohort of patients will be recruited to evaluate the primary outcome of change in CD4+ T cell count from baseline to the end of the study period after receiving NMN daily for 12 weeks. Secondary outcomes including safety and tolerability, impact on pro-inflammatory markers, increase in NAD+ levels, immune activation markers and change in quality of life questionnaire scores. Patients will participate in two in person visits including a baseline and end of study with two telephone encounters. Patients will take 1,000mg NMN daily for a total of 12 weeks during which they will keep a daily log of doses taken and any side effects experienced. At all visits labs and quality of life questionnaire will be completed with complete physical exam to be done at baseline and end of study visit.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected adults aged 18 years or older
- •Virologically suppressed on ART documented with two negative viral loads separated by at least 6 months
- •Confirmed diagnosis of immunological failure (CD4+ T cell count <350 cells/µL 2 years after effective ART initiation)
- •Willing to provide informed consent
排除标准
- •Active opportunistic infections
- •Known allergies or sensitivities to NMN or any components of the NMN supplement
- •Current or recent use of other supplements or medications known to affect NAD+ metabolism (Niacin, NR, NMNH, etc.)
- •Pregnancy or breastfeeding
- •Significant liver or kidney disease
- •Active malignancy
- •History of uncontrolled substance abuse
- •Severe medical conditions that might interfere with study participation
- •Unable to consent
研究组 & 干预措施
Treatment with 1,000mg Nicotinamide Mononucleotide daily
干预措施: Nicotinamide Mononucleotide (Dietary Supplement)
结局指标
主要结局
Primary Outcome
时间窗: 12 weeks
The primary outcome of this study will be the change in CD4+ T cell count from baseline to the end of the study period. \[normal range: 500-1500 cells/mm\^3; improved outcomes with increase to normal range\]
次要结局
- CD38(collected at baseline visit followed by monthly collections for total of 3 months)
- HS-CRP(collected at baseline visit followed by monthly collections for total of 3 months)
- HLA-DR expression(collected at baseline visit followed by monthly collections for total of 3 months)
- TNF-alpha(collected at baseline visit followed by monthly collections for total of 3 months)
- NAD(+) levels(collected at baseline visit followed by monthly collections for total of 3 months)
- IL-6(collected at baseline visit followed by monthly collections for total of 3 months)
- Changes on Quality-of-life Questionnaire (QOL): WHO QOL HIV BREF(collected at baseline visit followed by monthly collections for total of 3 months)