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Vaccines and Immunotherapies (VIT)


CTNPT 006: The Niaspan® study

Role of extended-released niacin on immune activation in HIV-infected patients treated with antiretroviral therapy: a proof-of-concept study

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About the study

This pilot study will evaluate the effect of a drug called Niaspan®, an extended-release form of niacin (ER niacin), in individuals living with HIV who are on antiretroviral therapy (ART). Researchers will examine the ability of an oral form of ER niacin to reduce immune activation and increase CD4 cells in persons with sub-optimal immune responses despite sustained virologic suppression from ART.

Study researchers believe that by regulating an amino acid called tryptophan, niacin may decrease T cell immune activation which may enhance CD4 recovery and improve neurocognitive functions. The effect of administering ER niacin in combination with ART will be measured against a regimen of ART alone.

Researchers will also evaluate the impact of this experimental treatment on the quality of life and neurocognitive functions in participating individuals.

About the disease/condition

Approximately 30 per cent of people taking ART do not achieve an adequate CD4 recovery (an increase in CD4 cell count) and remain at risk for disease progression and non-AIDS-related complications. Among factors associated with low CD4 recovery, T cell immune activation (CD4 and CD8 T cells expressing markers of activation such as CD38) represents one of the most important ones.

About the approach/intervention

Twenty participants will be enrolled into one of two study treatment groups:

Group 1: (immediate use) will receive ER niacin supplementation for 24 weeks followed by 24 weeks of antiretroviral therapy alone (observation)

Group 2: (deferred use) will undergo 24 weeks of ART alone (observation), followed by ER niacin supplementation for 24 weeks

Niaspan® (ER niacin) is an extended-released form of niacin, also known as vitamin B3. Though proven effective in reducing cholesterol levels in the blood, use of ER niacin in HIV-positive persons to reduce T cell immune activation and to improve neurocognitive functions has not been approved by Health Canada.

 

Eligibility Criteria

Individuals will be eligible for the study if they meet the following inclusion criteria:

Eligibility criteria

  • HIV infection confirmed by Western Blot
  • Aged 21 years old or older
  • Undetectable HIV viral load (<50 copies/mL) for at least 3 months
  • Current CD4 cell count <350 cells/mL
  • Receiving ART for at least the previous 12 months
  • Willing to give informed consent

Main exclusion criteria

  • Pregnant women
  • Prior history of hypersensitivity, reaction to niacin or any other component of the study drug
  • Active liver disease; active peptic ulcer; severe bleeding disorders; severe hypotension; Hepatitis B or C infection

Participating sites

Montreal Chest Institute (MUHC)(Montreal)
Dr. Bertrand Lebouché
T: 514-934-1934 ext. 32600
3650 St-Urbain
Montreal, Quebec H2X 2P4

Additional Information

If you would like more information on this clinical study, please refer to a participating site.

Principal Investigator
Dr. Bertrand Lebouché
Montreal Chest Hospital
T: 514-934-1934 ext. 32600

 
Publication:

Lebouche B, Jenabian M-A, Singer J, Graziani GM, Engler K, Trottier B, Thomas R, Brouillette M-J, 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;15(1):390.

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