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NCT Number: NCT06889142

Impact of NMN Supplementation on CD4+ T Cell Recovery in HIV Patients With Immunological Failure

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

nicotinamide mononucleotide

Dietary Supplement

The dietary supplement NMN [1,000mg] will be taken orally by participants daily for a total of 12 weeks

Other names: NMN

Primary outcomes

  1. Primary Outcome

    Time frame: 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]

Secondary outcomes

  1. CD38

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    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]

  2. HLA-DR expression

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    HLA-DR expression [healthy individuals <5-10% HLA DR CD 4+ T cell expression and <5%

  3. TNF-alpha

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    (Ref Interval: <=7.2) Cytokines- Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders

  4. NAD(+) levels

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    Ranges from 10-500 µM during normal physiological state; however, it's levels can vary by age as well as metabolic and disease states

  5. IL-6

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    (Ref Interval: <=2.0 pg/mL ) Cytokines- Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders

  6. HS-CRP

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    Ref Interval: <=3.0 mg/L

  7. Changes on Quality-of-life Questionnaire (QOL): WHO QOL HIV BREF

    Time frame: collected at baseline visit followed by monthly collections for total of 3 months

    Domain scores between 4-20 with higher score correlating with improved QOL

Study contacts

Contact information is provided by the study sponsor or research team.

Madelyn Mirande, DO

CONTACT

[email protected]

715-307-1273

Martin L. Gnoni, MD

CONTACT

[email protected]

513-568-7462

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Collaborators

  • DoNotAge.org

Registry information

Official study title

Proof-of-Concept Study: Investigating the Impact of NMN Supplementation on CD4+ T Cell Recovery in Virologically Suppressed HIV Patients With Immunological Failure

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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