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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by McGill University Health Center
Sponsor:
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Dr. Bertrand Lebouche, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT02018965
First received: December 17, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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:

  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

Condition Intervention Phase
HIV
Drug: Niacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Extended-release Niacin on Immune Activation in HIV-infected Patients Treated With Antiretroviral Therapy: a Proof-of-concept Study

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Comparison of the change in CD8CD38 percentage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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)

  • Comparison of the change in CD8CD38 percentage during the ER niacin + ART period [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in CD4 cell count and their subsets, including naïve, central memory and effector memory and Th17/Treg cells [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in inflammatory markers such as INF-α, IL-1, IL-6, IL-17, usCRP, LPS and D-dimers [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in plasmatic Trp levels [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in total cholesterol, HDL, LDL cholesterol and triglycerides [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

• 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.

Other Names:
  • Niaspan FCT®
  • extended-release(ER)Niacin
  • vitamin B3
Drug: Niacin

• 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.

Other Names:
  • Niaspan FCT®
  • extended-release(ER)Niacin
  • vitamin B3
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

• 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.

Other Names:
  • Niaspan FCT®
  • extended-release(ER)Niacin
  • vitamin B3
Drug: Niacin

• 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.

Other Names:
  • Niaspan FCT®
  • extended-release(ER)Niacin
  • vitamin B3

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018965

Contacts
Contact: Bertrand Lebouché, MD PhD 514-934-1934 ext 31340 bertrand.lebouche@gmail.com

Locations
Canada, Quebec
Montreal Chest Institute Recruiting
Montreal, Quebec, Canada, H2W1T7
Contact: Bertrand Lebouché, MD, PhD    514-934-1934 ext 31340    bertrand.lebouche@gmail.com   
Sponsors and Collaborators
McGill University Health Center
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Bertrand Lebouché, MD, PhD McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr. Bertrand Lebouche, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02018965     History of Changes
Other Study ID Numbers: CTN006
Study First Received: December 17, 2013
Last Updated: December 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
HIV
Extended-release Niacin
Immune activation

Additional relevant MeSH terms:
Niacin
Nicotinic Acids
Niacinamide
Vitamin B Complex
Vitamins
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014