NCT02018965

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 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

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-12-24
• Last updated: 2018-04-23

Locations

1 site across 1 country: Canada