PERSPECTIVE - HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 (HIV-1) RNA END-POINTS IN HIV CLINICAL-TRIALS - ISSUES IN INTERIM MONITORING AND EARLY STOPPING

Due to the desire to both shorten the length and reduce the size of cl inical trials in human immunodeficiency virus (HIV) disease, the use o f surrogate end points such as HIV-1 RNA is becoming increasingly stan dard. While these end points may be reasonable surrogates for the clin ical effectiveness of drugs, a key point in their use as trial end poi nts is the definition of a relevant duration of antiviral response. Th is definition is often complicated by the desire to perform interim re views of ongoing laboratory end point trials. Unlike clinical end poin t trials, in which early clinical response is generally indicative of longer-term follow-up, it is yet to be determined whether short-term v iral response adequately predicts the long-term durability of that res ponse.