Episodic antiretroviral therapy trial is halted early.
A major international drug trial designed to assess if episodic antiretroviral therapy would reduce side-effects and costs of treatment has been terminated much earlier than expected because patients receiving episodic treatment were twice as likely to develop clinical AIDS or die than did their counterparts on continuous antiretroviral therapy. “Large trials with clinical outcomes are needed to obtain definitive answers to important clinical research questions. SMART [Strategies for Management of Anti-Retroviral Therapy] is a good example of that”, explains James Neaton (University of Minnesota, MN, USA), a principal investigator of the study. According to Neaton, the important excess risk identified in the episodic treatment group, both for progression and serious complications, would likely have gone unnoticed in a small study. (excerpt)