Differences in implementation of HIV/AIDS clinical research in developed versus developing world: an evidence-based review on protease inhibitor use among women and minorities

Abstract

The aim of this revision is to evaluate ethnicity and gender rate of enrolment in registrative clinical trials of the protease inhibitors (Pis) from 1996 to 2009. Company-sponsored, phase II or III registrative clinical trials of PIs were evaluated. Forty-nine clinical trials were included. Clinical trials were conducted in centres in North America ( n = 39), Central-South America ( n = 22), Europe ( n = 22), Africa ( n = 8), Asia ( n = 5), Australia ( n = 10). Overall mean age was 39.6 years; median proportion of women was 16.3%. The most represented ethnic group was Caucasian. A test for trend over time (1996-2009) shows a significant increase in the proportion of women included ( P = 0.012), and a decrease in the proportion of Caucasians included, reaching borderline significance ( P = 0.061). An inverse correlation was observed between the proportion of Caucasians and that of women enrolled in each study ( r = 0.65, P < 0.0001). Women were less likely to be included in double-blind studies (11.2% versus 17%, P = 0.019). Clinical trials for treatment-naive subjects were more likely to enrol ethnicities other than Caucasian compared with Caucasian (44.7% versus 27.1 %, respectively, P = 0.04). Rates of enrolment of minorities in registrative clinical trials for PIs show a positive trend since 1996, mirroring the growing number of people of different ethnic groups accessing ART.