Lebouché 2014.

Trial name or title	The role of extended‐release niacin on immune activation and neurocognition in HIV‐positive patients treated with antiretroviral therapy (CTN PT006)
Methods	Country: Canada Setting: Chronic Viral Illness Service, Montreal Chest Institute of the McGill University Health Centre (MUHC), and the Cliniquemédicale l’Actuel, Montreal Design: randomized cross‐over trial
Participants	Inclusion criteria: 21 years or older, viral load < 50 copies/mL for the last 3 months, CD4+ T‐cell count ≤ 350 cells/μL; and on stable ART (ART unchanged for treatment failure (rebound in viral load)) for more than 12 months. Exclusion criteria: prior history of hypersensitivity reaction to niacin or any other component of the study drug; prior history of flushing; liver disease (including coinfection with hepatitis B or C virus) or unexplained persistent elevations of serum transaminases; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase > 2.5 times the upper limit of normal ; active duodenal or gastric peptic ulcer; active bleeding disorders; history of gout; active AIDS events in the last 3 months as determined by the treating physician; unstable angina or acute phase myocardial infarction; diabetic or potentially diabetic with hypercholesterolaemia; renal dysfunction; co‐enrolment in another study involving neurocognitive evaluation; or pregnant or nursing or planning to become pregnant.
Interventions	Immediate versus deferred use of ER niacin for 24 weeks. The administration of ER niacin will be titrated (weeks 0 to 4: 500 mg, weeks 5 to 12: 1000 mg, weeks 12 to 24: 2000 mg). All participants will receive ART
Outcomes	Primary outcome: T cell activation (change in percentage of CD8+ CD38+ HLA‐DR+ T‐cells) Secondary outcomes: change in total CD4 cell count
Starting date	February 2012
Contact information	bertrand.lebouche@mcgill.ca
Notes