HIV Clinical Trial - Niacin on Immune Activation : a Proof-of-concept

Status Completed

Clinical 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.

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02018965
Study type	Interventional
Source	McGill University Health Center
Contact
Status	Completed
Phase	Phase 2
Start date	November 2011
Completion date	June 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms