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From the University of Rochester Medical Center (Drs. Schifitto, Kieburtz, McDermott, and Epstein), Rochester, NY; the Johns Hopkins University School of Medicine (Drs. Sacktor and McArthur), Baltimore, MD; and Columbia University (Drs. Marder and Small), New York, NY.
Address correspondence and reprint requests to Dr. Giovanni Schifitto, University of Rochester, Department of Neurology, 601 Elmwood Avenue, Box 673, Rochester, NY 14642.
OBJECTIVE: To assess the safety and tolerability of lexipafant in HIV-associated cognitive impairment.
BACKGROUND: Cognitive impairment is the most common neurologic complication of advanced HIV-1 infection. There is evidence that a variety of inflammatory mediators, including platelet-activating factor (PAF), may contribute to neuronal injury. We hypothesized that lexipafant, a PAF antagonist, might improve cognitive dysfunction in HIV-infected people.
METHODS: We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the safety and tolerability of lexipafant 500 mg/day. The primary outcome measure for tolerability was the ability to complete the study on the originally assigned dosage of medication. Thirty patients with cognitive impairment were enrolled.
RESULTS: Lexipafant was safe and well tolerated. Ninety-three percent in the placebo group and 88% in the lexipafant group completed the study at the originally assigned dosage. Trends toward improvement were seen in neuropsychological performance, especially verbal memory, in the lexipafant treatment group.
CONCLUSIONS: This study shows that lexipafant, the first PAF antagonist used in HIV-associated cognitive impairment, is a safe and well tolerated compound. The observed trends toward improvement in neuropsychological test scores warrant the pursuit of a larger and longer efficacy trial to assess the impact of lexipafant on cognitive performance.
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