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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTriHealth Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nicotinamide Mononucleotide

Treatment groups

7 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

TriHealth Inc.

Lead sponsor

DoNotAge.org

Collaborator