TY - JOUR
T1 - Randomized trial of the platelet-activating factor antagonist lexipafant in HIV-associated cognitive impairment
AU - Schifitto, Giovanni
AU - Sacktor, N.
AU - Marder, K.
AU - McDermott, M. P.
AU - McArthur, J. C.
AU - Kieburtz, K.
AU - Small, S.
AU - Epstein, L. G.
PY - 1999/7/22
Y1 - 1999/7/22
N2 - 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.
AB - 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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U2 - 10.1212/wnl.53.2.391
DO - 10.1212/wnl.53.2.391
M3 - Article
C2 - 10430432
AN - SCOPUS:0033595183
SN - 0028-3878
VL - 53
SP - 391
EP - 396
JO - Neurology
JF - Neurology
IS - 2
ER -