Selegiline Transdermal System (STS) for HIV-associated cognitive impairment: Open-label report of ACTG 5090

Scott R. Evans, Tzu Min Yeh, Ned Sacktor, David B. Clifford, David Simpson, Eric N. Miller, Ronald J. Ellis, Victor Valcour, Christina M. Marra, Linda Millar, Giovanni Schifitto

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To assess the long-term safety (primary aim) and efficacy (secondary aim) of the MAO-B inhibitor Selegiline Transdermal System (STS) for the treatment of HIV-associated cognitive impairment. Background: HIV infection is associated with increased oxidative stress. In vitro and animal studies have shown that selegiline can reduce oxidative stress levels while enhancing the synthesis of neurotrophic factors. We conducted and reported a 24-week, double-blind, placebo-controlled study with STS in HIV-infected individuals with cognitive impairment (ACTG 5090). We now report the results of the 24-week open-label follow-up. Method: Subjects received either 3 mg/24 h or 6 mg/24 h STS daily. The primary efficacy endpoint was changes in the mean of z scores of six neuropsychological tests (NPZ-6). Additional outcomes included NPZ-8 and NPZ scores by cognitive domain. Results: 86 subjects were enrolled. There were few severe adverse experiences (n = 13). There was no significant change in NPZ-6 score, whereas significant changes were observed in NPZ-8 score and several cognitive domains. Conclusion: Long-term use of selegiline was safe and well tolerated in this HIV cohort of HIV with cognitive impairment. Cognitive improvement may be delayed in neuroprotective trials, suggesting that trials longer than 6 months may be necessary to assess the efficacy of putative neuroprotective agents.

Original languageEnglish (US)
Pages (from-to)437-446
Number of pages10
JournalHIV Clinical Trials
Volume8
Issue number6
DOIs
StatePublished - Nov 2007

Keywords

  • HIV
  • HIV dementia
  • HIV-associated cognitive impairment
  • Selegiline Transdermal System

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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