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HIV Clin Trials. 2010 Jan-Feb;11(1):59-67. doi: 10.1310/hct1101-59.

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

Author information

1
Harvard School of Public Health, Boston, Massachusetts, USA. yu.zhao@fda.hhs.gov

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00000867.

PMID:
20400412
PMCID:
PMC2981797
DOI:
10.1310/hct1101-59
[Indexed for MEDLINE]
Free PMC Article

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