Randomized trial of the platelet-activating factor antagonist lexipafant in HIV-associated cognitive impairment

Giovanni Schifitto, N. Sacktor, K. Marder, M. P. McDermott, J. C. McArthur, K. Kieburtz, S. Small, L. G. Epstein

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)391-396
Number of pages6
JournalNeurology
Volume53
Issue number2
DOIs
StatePublished - Jul 22 1999

ASJC Scopus subject areas

  • Clinical Neurology

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