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 (Pls) 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 Pls show a positive trend since 1996, mirroring the growing number of people of different ethnic groups accessing ART.

Protease Inhibitors or NNRTIs as First-Line HIV-1 Treatment in West Africa (PIONA): A Randomized Controlled Trial

“…The number of randomised trials in Sub-Saharan Africa remains low, even though the majority of people living with HIV are treated in this low-resource setting. 23 The OCTANE trials 12,24 were some of the first and largest randomised controlled trials to compare PIs with NNRTIs in Africa, but only included females. The OCTANE Trial 1 indicated that NVP was inferior to LPV/r as an initial ART among women with prior single-dose NVP exposure, 24 in accordance with later findings from the Democratic Republic of Congo.…”