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

TitleMemantine for AIDS dementia complex: open-label report of ACTG 301.
Publication TypeJournal Article
Year of Publication2010
AuthorsZhao Y, Navia BA, Marra CM, Singer EJ, Chang L, Berger J, Ellis RJ, Kolson DL, Simpson D, Miller EN, Lipton SA, Evans SR, Schifitto G
Corporate AuthorsAdult Aids Clinical Trial Group(ACTG) 301 Team
JournalHIV Clin Trials
Volume11
Issue1
Pagination59-67
Date Published2010 Jan-Feb
ISSN1528-4336
KeywordsAdult, AIDS Dementia Complex, Dopamine Agents, Double-Blind Method, Female, HIV-1, Humans, Male, Memantine, Middle Aged, Neuropsychological Tests, Statistics, Nonparametric
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.

DOI10.1310/hct1101-59
Alternate JournalHIV Clin Trials
PubMed ID20400412
PubMed Central IDPMC2981797
Grant ListAI38858 / AI / NIAID NIH HHS / United States
U01 AI025897 / AI / NIAID NIH HHS / United States
U01 AI025897-17 / AI / NIAID NIH HHS / United States
U01 AI027661-19S5 / AI / NIAID NIH HHS / United States
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U01 AI068636-05 / AI / NIAID NIH HHS / United States
U01 AI069424 / AI / NIAID NIH HHS / United States
U01 AI069424-05 / AI / NIAID NIH HHS / United States
U01 AI069432 / AI / NIAID NIH HHS / United States
U01 AI069432-05 / AI / NIAID NIH HHS / United States
U01 AI069434 / AI / NIAID NIH HHS / United States
U01 AI069434-05 / AI / NIAID NIH HHS / United States
U01 AI069467 / AI / NIAID NIH HHS / United States
U01 AI069467-05 / AI / NIAID NIH HHS / United States
U01 AI069471 / AI / NIAID NIH HHS / United States
U01 AI069471-05 / AI / NIAID NIH HHS / United States
U01 AI069472 / AI / NIAID NIH HHS / United States
U01 AI069472-05 / AI / NIAID NIH HHS / United States
U01 AI069477 / AI / NIAID NIH HHS / United States
U01 AI069477-05 / AI / NIAID NIH HHS / United States
U01 AI069495 / AI / NIAID NIH HHS / United States
U01 AI069495-05 / AI / NIAID NIH HHS / United States
U01 AI069501 / AI / NIAID NIH HHS / United States
U01 AI069501-05 / AI / NIAID NIH HHS / United States
U01 AI069502 / AI / NIAID NIH HHS / United States
U01 AI069502-05 / AI / NIAID NIH HHS / United States
U01 AI069511 / AI / NIAID NIH HHS / United States
U01 AI069511-05 / AI / NIAID NIH HHS / United States
U01AI068636 / AI / NIAID NIH HHS / United States
UM1 AI069477 / AI / NIAID NIH HHS / United States
UM1 AI069511 / AI / NIAID NIH HHS / United States