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

March 31, 2025 updated by: TriHealth Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with 1,000mg Nicotinamide Mononucleotide daily
Dietary supplement: Nicotinamide Mononucleotide
The dietary supplement NMN [1,000mg] will be taken orally by participants daily for a total of 12 weeks
Other Names:
  • NMN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
collected at baseline visit followed by monthly collections for total of 3 months
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%
collected at baseline visit followed by monthly collections for total of 3 months
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
collected at baseline visit followed by monthly collections for total of 3 months
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
collected at baseline visit followed by monthly collections for total of 3 months
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
collected at baseline visit followed by monthly collections for total of 3 months
HS-CRP
Time Frame: collected at baseline visit followed by monthly collections for total of 3 months
Ref Interval: <=3.0 mg/L
collected at baseline visit followed by monthly collections for total of 3 months
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
collected at baseline visit followed by monthly collections for total of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriHealth Inc.

Collaborators

DoNotAge.org

Investigators

  • Study Chair: Madelyn Mirande, DO, TriHealth Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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