Targeting the Cholinergic Pathway in HIV-associated Inflammation and Cognitive Dysfunction
Brief description of study
Although anti-retroviral therapy (ART) enhances life expectancy and overall quality of life (QoL), people with HIV (PWH) are increasingly vulnerable to non-AIDS-related diseases including HIV-associated neurocognitive disorders (HANDs). Inflammation is thought to contribute to HANDs and tobacco use may further increase inflammation. However, nicotine alone has anti-inflammatory effects suggesting that certain medications [e.g., galantamine (GAL)] may decrease inflammation and prevent HANDs. In this double-blind, placebo-controlled crossover study, PWH (N=120; 60 smokers, 60 nonsmokers) will be randomized to 12 weeks of GAL or placebo, followed by a 4-week washout, then 12 weeks of GAL or placebo (arms switched). All subjects must be on ART and the GAL dose will follow FDA guidelines. At the beginning and end of each treatment phase, blood samples will be taken to measure inflammation and viral load. Cognitive function and clinical outcomes (e.g., QoL) will be measured at baseline and at 4-week intervals during each treatment phase. The primary outcomes are inflammation and cognitive function (processing speed, verbal learning/memory, executive function). This study could improve health outcomes among HIV-infected individuals.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Tobacco Use Disorder,tobacco use disorder
-
Age: Between 30 Years - 100 Years
-
Gender: All
Updated on
02 Nov 2021.
Study ID: 828125
