CompletedNCT02018965Updated Apr 23, 2018

Niacin on Immune Activation : a Proof-of-concept Study

A Phase 2 interventional study of Niacin and Niacin in HIV, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-23.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 16
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

There are a number of powerful anti-HIV drugs, which keep the virus at undetectable levels and enable HIV-infected individuals to live longer. However, some participants taking anti-HIV drugs do not achieve an adequate CD4 recovery and remain at risk for developing AIDS and non-AIDS-related complications.

ER niacin (PrNiaspanFCT®) is an extended-released form of niacin, also known as vitamin B3. Niacin is effective in reducing cholesterol levels in the blood. This drug has been known for a long-time to treat dyslipidemia and it is used to improve favourably all the lipoprotein risk factors for artherosclerotic disease, particularly in HIV-infected patients. Recent scientific research shows that regular consumption of niacin-rich foods may also provide protection against Alzheimer's disease and age-related cognitive decline.

The purpose of this study is to find out:

If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could reduce T cell immune activation and enhance CD4 recovery;
If ER niacin can improve your quality of life and your neurocognitive functions

Read the detailed description

Primary objective

To assess the impact of extended-release niacin (ER niacin) supplementation + antiretroviral therapy (ART) compared to ART alone on T-cell immune activation as defined by CD8CD38 percentage

Secondary objectives

To assess the change in total CD4 T-cell count after ER niacin administration
To explore the effect of ER niacin on regulatory T-cells (Th-17/Treg) in blood and gut mucosa samples
To explore the effect of ER niacin on cytokines and inflammatory markers such as INF-α, IL-1, IL-6, IL-17, D-dimers, usCRP and LPS
To assess the influence of ER niacin on tryptophan (Trp) plasmatic levels
To assess changes in cholesterol and triglycerides
To explore ER niacin tolerance
To evaluate the impact of ER niacin on quality of life (QoL), fatigue, depression, and neurocognitive scores

Population: All participants will have an undetectable HIV viral load (\< 50 copies/mL) for at least 3 months, current CD4 cell count of \< 350 cells/µL and be receiving ART for at least the previous 12 months.

Sample size: N=20

Conditions studied

Keywords

HIV
Extended-release Niacin
Immune activation

In context

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Participants must meet all of the following criteria within four weeks prior to the Week 0 (Baseline) Visit to be considered eligible for entry into the study:

Documented HIV infection by Western Blot, EIA assays or viral load assay
Aged 21 or older
Viral load \< 50 copies/mL for the last 3 months
CD4 cell count \< 350 cells/µL
On stable ART, i.e., ART unchanged for treatment failure (rebound in viral load) for more than 12 months
Able to communicate adequately in either French or English
Able and willing to give written informed consent prior to enrolment including access to relevant medical records.

Participants are not eligible to participate in the study if any of the following conditions are met:

Pregnant, breastfeeding or planning to become pregnant during the course of the study. All fecund female participants must undergo a pregnancy test, with a negative result, prior to being eligible to participate in the study
Prior history of hypersensitivity reaction to niacin or any other component of the study drug
Prior history of flushing
Active liver disease or unexplained persistent elevations of serum transaminases
Co-infection with active Hepatitis B or C virus (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load or positive anti HCV antibodies with a detectable HCV RNA viral load)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase >2.5 x upper limit of normal (ULN)
Active duodenal or gastric peptic ulcer
Active bleeding disorders
History of gout
Active AIDS events in the last 3 months as determined by the treating physician
Unstable angina or acute phase myocardial infarction, with or without vasodilator agents
Diabetic or potentially diabetic with hypercholesterolaemia
Renal dysfunction.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Other
ER niacin followed by ART alone
For Arm 1, ER niacin administration begins Week 0 and ends Week 24 (defined as 'immediate use' arm).
Drug: Niacin
Other
ART alone followed by ER niacin
For Arm 2, ER niacin administration begins after the Week 24 Visit and ends Week 48 (defined as 'deferred use' arm).
Drug: Niacin

Interventions

DrugNiacin
• Group 1: This group will receive an initial dose of ER niacin 500 mg by mouth, the first evening from week 0 to week 4 then increase it to 1000 mg once a day from week 5 to week 8, then increase to 1500 mg from week 9 to week 12 then increase to 2000 mg until weeks 24 and then stopped. Participants will continue to take their ART treatment as prescribed throughout the study.
Also known as: Niaspan FCT®, extended-release(ER)Niacin, vitamin B3
DrugNiacin
• Group 2: This group will not receive ER niacin for the first 24 weeks. This group will receive an initial dose of ER niacin 500 mg the first evening at week 25 by mouth from week 25 to week 28 then increase it to 1000 mg once a day from week 29 to week 32, then increase to 1500 mg from week 33 to week 36 then increase to 2000 mg until week 48 and then stopped. Participants will continue to take their ART treatment as prescribed throughout the study.
Also known as: Niaspan FCT®, extended-release(ER)Niacin, vitamin B3

What researchers measure

Primary outcomes

Comparison of the change in CD8CD38 percentage
Comparison of the change in CD8CD38 percentage from Week 0 to Week 24 of Arm 1 (ER niacin + ART) to Week 0 to Week 24 of Arm 2 (ART alone) (ER niacin treatment + ART vs. ART alone for 24 weeks)
Time frame: 24 weeks
Comparison of the change in CD8CD38 percentage during the ER niacin + ART period
Comparison of the change in CD8CD38 percentage during the ER niacin + ART period with the change in CD8CD38 during the ART alone period within each arm (Week 0 to Week 24 vs. Week 24 to Week 48 for Arm 1 and Week 24 to Week 48 vs. Week 0 to Week 24 for Arm 2); if the difference between ER niacin versus control is similar in the two time periods, the treatment effect will be pooled adjusting for treatment order
Time frame: 48 weeks

Secondary outcomes

Change in CD4 cell count and their subsets, including naïve, central memory and effector memory and Th17/Treg cells
Time frame: 48 weeks
Changes in inflammatory markers such as INF-α, IL-1, IL-6, IL-17, usCRP, LPS and D-dimers
Time frame: 48 weeks
Change in plasmatic Trp levels
Time frame: 48 weeks
Changes in total cholesterol, HDL, LDL cholesterol and triglycerides
Time frame: 48 weeks

Study locations

1 site

Montreal Chest Institute
Montreal, Quebec H2W1T7, Canada

References and documents

Publications

Lebouche B, Jenabian MA, Singer J, Graziani GM, Engler K, Trottier B, Thomas R, Brouillette MJ, Routy JP. The role of extended-release niacin on immune activation and neurocognition in HIV-infected patients treated with antiretroviral therapy - CTN PT006: study protocol for a randomized controlled trial. Trials. 2014 Oct 7;15:390. doi: 10.1186/1745-6215-15-390. PubMed 25293882 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02018965
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: CIHR Canadian HIV Trials Network
Responsible party: Dr. Bertrand Lebouche (MD, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted: Dec 24, 2013
Start date: Nov 2011
Primary completion: Jun 2017
Completion: Jun 2017
Last update: Apr 23, 2018

Study contacts

Bertrand Lebouché, MD, PhD

principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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