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HIVPhase 2NCT02018965

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

A Phase 2 study testing Niacin in people with HIV, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Niacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteCanada
Study dates
Nov 2011to Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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:

  1. Documented HIV infection by Western Blot, EIA assays or viral load assay
  2. Aged 21 or older
  3. Viral load < 50 copies/mL for the last 3 months
  4. CD4 cell count < 350 cells/µL
  5. On stable ART, i.e., ART unchanged for treatment failure (rebound in viral load) for more than 12 months
  6. Able to communicate adequately in either French or English
  7. 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:

  1. 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
  2. Prior history of hypersensitivity reaction to niacin or any other component of the study drug
  3. Prior history of flushing
  4. Active liver disease or unexplained persistent elevations of serum transaminases
  5. 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)
  6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase >2.5 x upper limit of normal (ULN)
  7. Active duodenal or gastric peptic ulcer
  8. Active bleeding disorders
  9. History of gout
  10. Active AIDS events in the last 3 months as determined by the treating physician
  11. Unstable angina or acute phase myocardial infarction, with or without vasodilator agents
  12. Diabetic or potentially diabetic with hypercholesterolaemia
  13. Renal dysfunction.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Montreal Chest Institute

    Montreal, Quebec, H2W1T7

Other trials in Canada

About this study

Official title: Role of Extended-release Niacin on Immune Activation in HIV-infected Patients Treated With Antiretroviral Therapy: a Proof-of-concept Study

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.

Read more

The purpose of this study is to find out:

  1. If ER niacin combined with anti-HIV drugs, compared with anti-HIV drugs alone, could reduce T cell immune activation and enhance CD4 recovery;
  2. 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
HIV
Being tested
Niacin
Keywords
HIV, Extended-release Niacin, Immune activation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiacinDrug

    Also called Niaspan FCT®, extended-release(ER)Niacin, vitamin B3

    • 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.

  • NiacinDrug

    Also called Niaspan FCT®, extended-release(ER)Niacin, vitamin B3

    • 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.

Study groups in NCT02018965
Study groupRoleWhat they receive
ER niacin followed by ART aloneOtherFor Arm 1, ER niacin administration begins Week 0 and ends Week 24 (defined as 'immediate use' arm).
Receives: Drug: Niacin
ART alone followed by ER niacinOtherFor Arm 2, ER niacin administration begins after the Week 24 Visit and ends Week 48 (defined as 'deferred use' arm).
Receives: Drug: Niacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 24 weeks

  2. 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

    Measured: 48 weeks

Secondary outcomes (4)

  1. Change in CD4 cell count and their subsets, including naïve, central memory and effector memory and Th17/Treg cells

    Measured: 48 weeks

  2. Changes in inflammatory markers such as INF-α, IL-1, IL-6, IL-17, usCRP, LPS and D-dimers

    Measured: 48 weeks

  3. Change in plasmatic Trp levels

    Measured: 48 weeks

  4. Changes in total cholesterol, HDL, LDL cholesterol and triglycerides

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2013 (estimated)
  2. Study startNov 2011
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02018965
Sponsor's protocol ID
CTN006
Status last verified
Apr 2018
First submitted
17 Dec 2013
Last updated
23 Apr 2018
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niacin in people with HIV, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the change in CD8CD38 percentage (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02018965, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.

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