HIV clinical trials · 2010
Memantine for AIDS dementia complex: open-label report of ACTG 301.
СтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Zhao Yu, Navia Bradford A, Marra Christina M, Singer Elyse J, Chang Linda, Berger Joseph, Ellis Ronald J, Kolson Dennis L, Simpson David, Miller Eric N, Lipton Stuart A, Evans Scott R, Schifitto Giovanni, Adult Aids Clinical Trial Group (ACTG) 301 Team
Аннотация
OBJECTIVE: To evaluate the long-term safety and efficacy of memantine use as treatment of HIV-associated cognitive impairment.
BACKGROUND: The results of a 20-week, randomized, double-blind, placebo-controlled trial of memantine in HIV-infected participants with cognitive impairment (ACTG 301) were previously reported. We report the results of the up-to-60-week open-label phase following the double-blind phase.
METHOD: Participants received open-label memantine and were escalated to a 40 mg/day dose or their maximum tolerated dose in the double- blind phase. Adverse experiences were used to evaluate safety, and changes in the mean of eight neuropsychological test scores (NPZ-8) were used to evaluate efficacy.
RESULTS: Ninety-nine participants entered the initial 12-week open-label phase and 45 in the additional 48-week extension. Twenty-seven participants reported severe adverse experiences. During the initial 12-week open-label phase, participants randomized to memantine in the double-blind phase had a statistically significant higher improvement in NPZ-8 compared to those randomized to placebo in the double-blind phase. No statistically significant NPZ-8 changes were detected during the 48-week extension.
CONCLUSION: Long-term use of memantine appears safe and tolerable. Future randomized studies with longer follow-up are necessary to establish efficacy of memantine for the treatment of HIV-associated cognitive impairment.
BACKGROUND: The results of a 20-week, randomized, double-blind, placebo-controlled trial of memantine in HIV-infected participants with cognitive impairment (ACTG 301) were previously reported. We report the results of the up-to-60-week open-label phase following the double-blind phase.
METHOD: Participants received open-label memantine and were escalated to a 40 mg/day dose or their maximum tolerated dose in the double- blind phase. Adverse experiences were used to evaluate safety, and changes in the mean of eight neuropsychological test scores (NPZ-8) were used to evaluate efficacy.
RESULTS: Ninety-nine participants entered the initial 12-week open-label phase and 45 in the additional 48-week extension. Twenty-seven participants reported severe adverse experiences. During the initial 12-week open-label phase, participants randomized to memantine in the double-blind phase had a statistically significant higher improvement in NPZ-8 compared to those randomized to placebo in the double-blind phase. No statistically significant NPZ-8 changes were detected during the 48-week extension.
CONCLUSION: Long-term use of memantine appears safe and tolerable. Future randomized studies with longer follow-up are necessary to establish efficacy of memantine for the treatment of HIV-associated cognitive impairment.