HAD and the need for new trial design methodology

Abstract

The study by Schifitto et al. in this issue raises important points in relation to AIDS dementia complex – now known as HIV associated dementia (HAD) – and its less severe forms of minor and asymptomatic neurocognitive impairment. These new terms are the result of a consensus working group convened under the auspices of the National Institutes of Mental Health to reappraise HAD in the HAART era. Schifitto et al. conducted a randomized double-blind placebo controlled trial of adding memantine, a weak N-methyl D-aspartate receptor antagonist, to stable background HAART in HAD patients. Unfortunately, there was no benefit at week 16 although at week 20, in the washout period off the drug, there was some evidence of benefit. In general, the Schifitto et al. paper raises issues related to the importance of HAD itself in the context of HAART and methodological issues associated with clinical trials of novel agents in HAD. This journal is to be lauded for its decision to publish the study despite its negative results.