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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

proof of concept

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with 1,000mg Nicotinamide Mononucleotide daily

Group Type EXPERIMENTAL

Nicotinamide Mononucleotide

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nicotinamide Mononucleotide

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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NMN

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No