CTNPT 006: The Niaspan® study

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

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.

Study Approach

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.

Results and Conclusion

The researchers administered ER niacin once daily for 24 weeks to 20 participants who were on ART with CD4 ≤350 cells/µl, despite an undetectable viral load for at least three months. A total of 13 participants completed the study – four participants were lost to follow-up or personal reasons and three were discontinued due to comorbidity risks. It was determined that despite the regimen being well tolerated by the participants, it did not improve systemic inflammation or CD4 cell recovery. In this study, the researchers concluded that ER niacin is not effective to overcome chronic inflammation in people living with HIV.