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AzTrials

Human Immunodeficiency VirusNCT06889142

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

A study testing Nicotinamide Mononucleotide in people with Human Immunodeficiency Virus, run by TriHealth Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Nicotinamide Mononucleotide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
No sites listed yet
Study dates
Apr 2025to Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • History of uncontrolled substance abuse
  • Severe medical conditions that might interfere with study participation
  • Unable to consent

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Martin L. Gnoni, MD contact

513-568-7462

martin_gnoni@trihealth.com

Madelyn Mirande, DO contact

715-307-1273

madelyn_mirande@trihealth.com

About this study

Official title: Proof-of-Concept Study: Investigating the Impact of NMN Supplementation on CD4+ T Cell Recovery in Virologically Suppressed 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.

Being tested
Nicotinamide Mononucleotide
Keywords
HIV, immunologic failure, proof of concept, CD4+ T cell recovery, immunological non-responders, Nicotinamide Mononucleotide
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotinamide MononucleotideDietary supplement

    Also called NMN

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

Study groups in NCT06889142
Study groupRoleWhat they receive
Treatment with 1,000mg Nicotinamide Mononucleotide dailyExperimentalNot described
Receives: Dietary Supplement: Nicotinamide Mononucleotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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]

    Measured: 12 weeks

Secondary outcomes (7)

  1. 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]

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

  2. HLA-DR expression

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

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

  3. TNF-alpha

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

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

  4. 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

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

  5. IL-6

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

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

  6. HS-CRP

    Ref Interval: <=3.0 mg/L

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
proof of concept
Masking
None (open label)
Enrolment
7 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06889142
Sponsor's protocol ID
24-089
Status last verified
Mar 2025
First submitted
3 Mar 2025
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi H, Enriquez A, Rapadas M, Martin EMMA, Wang R, Moreau J, Lim CK, Szot JO, Ip E, Hughes JN, Sugimoto K, Humphreys DT, McInerney-Leo AM, Leo PJ, Maghzal GJ, Halliday J, Smith J, Colley A, Mark PR, Collins F, Sillence DO, Winlaw DS, Ho JWK, Guillemin GJ, Brown MA, Kikuchi K, Thomas PQ, Stocker R, Giannoulatou E, Chapman G, Duncan EL, Sparrow DB, Dunwoodie SL. NAD Deficiency, Congenital Malformations, and Niacin Supplementation. N Engl J Med. 2017 Aug 10;377(6):544-552. doi: 10.1056/NEJMoa1616361.

    PubMed 28792876

  • Braidy N, Berg J, Clement J, Khorshidi F, Poljak A, Jayasena T, Grant R, Sachdev P. Role of Nicotinamide Adenine Dinucleotide and Related Precursors as Therapeutic Targets for Age-Related Degenerative Diseases: Rationale, Biochemistry, Pharmacokinetics, and Outcomes. Antioxid Redox Signal. 2019 Jan 10;30(2):251-294. doi: 10.1089/ars.2017.7269. Epub 2018 May 11.

    PubMed 29634344

  • Song Q, Zhou X, Xu K, Liu S, Zhu X, Yang J. The Safety and Antiaging Effects of Nicotinamide Mononucleotide in Human Clinical Trials: an Update. Adv Nutr. 2023 Nov;14(6):1416-1435. doi: 10.1016/j.advnut.2023.08.008. Epub 2023 Aug 22.

    PubMed 37619764

  • Lebouche B, Jenabian MA, Singer J, Graziani GM, Engler K, Trottier B, Thomas R, Brouillette MJ, Routy JP. The role of extended-release niacin on immune activation and neurocognition in HIV-infected patients treated with antiretroviral therapy - CTN PT006: study protocol for a randomized controlled trial. Trials. 2014 Oct 7;15:390. doi: 10.1186/1745-6215-15-390.

    PubMed 25293882

  • Mo Y, Yue M, Yim LY, Zhou R, Yu C, Peng Q, Zhou Y, Luk TY, Lui GC, Huang H, Lim CYH, Wang H, Liu L, Sun H, Wang J, Song Y, Chen Z. Nicotinamide mononucleotide impacts HIV-1 infection by modulating immune activation in T lymphocytes and humanized mice. EBioMedicine. 2023 Dec;98:104877. doi: 10.1016/j.ebiom.2023.104877. Epub 2023 Nov 17.

    PubMed 37980794

  • MD MG. Unveiling the Nexus of CD38 Overactivation, NAD+ Depletion, and Mitochondrial Dysfunction in Immunological Failure Among Virologically Suppressed HIV Patients. 2024(https://nortonhealthcaremedicaljournal.scholasticahq.com/article/118564-unveiling-the-nexus-of-cd38-overactivation-nad-depletion-and-mitochondrial-dysfunction-in-immunological-failure-among-virologically-suppressed-hiv).

  • Zhu A, Real F, Zhu J, Greffe S, de Truchis P, Rouveix E, Bomsel M, Capron C. HIV-Sheltering Platelets From Immunological Non-Responders Induce a Dysfunctional Glycolytic CD4+ T-Cell Profile. Front Immunol. 2022 Feb 11;12:781923. doi: 10.3389/fimmu.2021.781923. eCollection 2021.

    PubMed 35222352

  • Fan L, Li P, Yu A, Liu D, Wang Z, Wu Y, Zhang D, Zou M, Ma P. Prevalence of and prognosis for poor immunological recovery by virally suppressed and aged HIV-infected patients. Front Med (Lausanne). 2023 Oct 19;10:1259871. doi: 10.3389/fmed.2023.1259871. eCollection 2023.

    PubMed 37928477

  • Dessie G, Mulugeta H, Wagnew F, Zegeye A, Kiross D, Negesse A, Aynalem YA, Getaneh T, Ohringer A, Burrowes S. Immunological Treatment Failure Among Adult Patients Receiving Highly Active Antiretroviral Therapy in East Africa: A Systematic Review and Meta-Analysis. Curr Ther Res Clin Exp. 2021 Jan 5;94:100621. doi: 10.1016/j.curtheres.2020.100621. eCollection 2021.

    PubMed 34306262

  • Carvalho-Silva WHV, Andrade-Santos JL, Souto FO, Coelho AVC, Crovella S, Guimaraes RL. Immunological recovery failure in cART-treated HIV-positive patients is associated with reduced thymic output and RTE CD4+ T cell death by pyroptosis. J Leukoc Biol. 2020 Jan;107(1):85-94. doi: 10.1002/JLB.4A0919-235R. Epub 2019 Nov 5.

    PubMed 31691351

  • Burnie J, Fernandes C, Chaphekar D, Wei D, Ahmed S, Persaud AT, Khader N, Cicala C, Arthos J, Tang VA, Guzzo C. Identification of CD38, CD97, and CD278 on the HIV surface using a novel flow virometry screening assay. Sci Rep. 2023 Dec 27;13(1):23025. doi: 10.1038/s41598-023-50365-0.

    PubMed 38155248

  • Bono V, Augello M, Tincati C, Marchetti G. Failure of CD4+ T-cell Recovery upon Virally-Effective cART: an Enduring Gap in the Understanding of HIV+ Immunological non-Responders. New Microbiol. 2022 Jul;45(3):155-172.

    PubMed 35920870

Questions about this trial

What is this clinical trial studying?

A study testing Nicotinamide Mononucleotide in people with Human Immunodeficiency Virus, run by TriHealth Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin L. Gnoni, MD (513-568-7462, martin_gnoni@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06889142, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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