Memantine for AIDS dementia complex: open-label report of ACTG 301.
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.


METHODS
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.


CONCLUSIONS
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.
Zhao
Yu
Y
Harvard School of Public Health, Boston, Massachusetts, USA. yu.zhao@fda.hhs.gov
Navia
Bradford A
BA
Marra
Christina M
CM
Singer
Elyse J
EJ
Chang
Linda
L
Berger
Joseph
J
Ellis
Ronald J
RJ
Kolson
Dennis L
DL
Simpson
David
D
Miller
Eric N
EN
Lipton
Stuart A
SA
Evans
Scott R
SR
Schifitto
Giovanni
G
D015526:AIDS Dementia Complex / Q000188:drug therapy* / Q000523:psychology; D000328:Adult; D015259:Dopamine Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D015497:HIV-1; D006801:Humans; D008297:Male; D008559:Memantine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009483:Neuropsychological Tests; D018709:Statistics, Nonparametric
D015259:Dopamine Agents; D008559:Memantine
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