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.
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
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
Single group
Nicotinamide Mononucleotide
Dietary supplementThe dietary supplement NMN \[1,000mg\] will be taken orally by participants daily for a total of 12 weeks
Primary Outcome
The primary outcome of this study will be the change in CD4+ T cell count from baseline to the end of the study period. \[normal range: 500-1500 cells/mm\^3; improved outcomes with increase to normal range\]
CD38
Changes in immune activation markers - CD38 expression \[healthy individuals expression on T cell \<10-20%, untreated HIV elevated \>60-90%, HIV on ART \~ 20-30%; low percentage correlates with improved immune function\]
HLA-DR expression
HLA-DR expression \[healthy individuals \<5-10% HLA DR CD 4+ T cell expression and \<5%
TNF-alpha
(Ref Interval: \<=7.2) Cytokines- Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders
NAD(+) levels
Ranges from 10-500 µM during normal physiological state; however, it's levels can vary by age as well as metabolic and disease states
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TriHealth Inc.
Lead sponsor
DoNotAge.org
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
