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

NCTNCT06889142Other id24-089

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Overview

Status: Not yet recruiting
Phase: Not applicable
Enrollment: 7 participants (estimated)
Sponsor: TriHealth Inc. · Other
Design: Allocation not applicable · Open label (no masking)
Countries: Not stated
Start: Apr 2025 (estimated)
Primary completion: Jul 2025 (estimated)
Completion: Jul 2025 (estimated)
First posted: 21 Mar 2025
Last update posted: 3 Apr 2025
Conditions: Human Immunodeficiency Virus

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20252026

N/A
Impact of NMN Supplementation on CD4+ T Cell Recovery in HIV Patients With Immunological Failure
NCT06889142
est. Apr 2025 to est. Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Nicotinamide MononucleotideDietary supplement

Arms1

Experimental
Treatment with 1,000mg Nicotinamide Mononucleotide daily

Primary outcomes1

Outcomes the sponsor listed as primary.

Primary Outcome
Time frame · 12 weeks
Registry description
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(7)

CD38
Time frame · collected at baseline visit followed by monthly collections for total of 3 months
Registry description
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
Time frame · collected at baseline visit followed by monthly collections for total of 3 months
Registry description
HLA-DR expression \[healthy individuals \<5-10% HLA DR CD 4+ T cell expression and \<5%
TNF-alpha
Time frame · collected at baseline visit followed by monthly collections for total of 3 months
Registry description
(Ref Interval: \<=7.2) Cytokines- Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders
NAD(+) levels
Time frame · collected at baseline visit followed by monthly collections for total of 3 months
Registry description
Ranges from 10-500 µM during normal physiological state; however, it's levels can vary by age as well as metabolic and disease states
IL-6
Time frame · collected at baseline visit followed by monthly collections for total of 3 months
Registry description
(Ref Interval: \<=2.0 pg/mL ) Cytokines- Results are used to understand the pathophysiology of immune, infectious, or inflammatory disorders
HS-CRP
Time frame · collected at baseline visit followed by monthly collections for total of 3 months
Registry description
Ref Interval: \<=3.0 mg/L
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
Registry description
Domain scores between 4-20 with higher score correlating with improved QOL

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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