Memantine for AIDS Dementia Complex: Open-Label Report of ACTG 301

作者：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

来源：HIV Clinical Trials, 2010, 11(1): 59-67.

DOI：10.1310/hct1101-59

• AIDS dementia
• cognitive impairment
• memantine
• HIV

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.

• 出版日期2010-2