NCT06889142Not yet recruiting
Impact of NMN Supplementation on CD4+ T Cell Recovery in HIV Patients With Immunological Failure
Proof-of-Concept Study: Investigating the Impact of NMN Supplementation on CD4+ T Cell Recovery in Virologically Suppressed HIV Patients With Immunological Failure
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- Apr 2025
- Primary completion date
- Jul 2025
- Lead sponsor
- TriHealth Inc.
- Diseases
- HIV
- NCT number
- NCT06889142
What you commit to
- Study type: Interventional
- Planned participants: 7
- From Apr 2025 to the primary completion date, Jul 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent use of other supplements or medications known to affect NAD+ metabolism (Niacin, NR, NMNH, etc.)
Other illness
- Active opportunistic infections
- Known allergies or sensitivities to NMN or any components of the NMN supplement
- Significant liver or kidney disease
- Active malignancy
- History of uncontrolled substance abuse
- Severe medical conditions that might interfere with study participation
Other
- Pregnancy or breastfeeding
- Unable to consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.