期刊
HIV MEDICINE
卷 12, 期 3, 页码 183-191出版社
WILEY-BLACKWELL
DOI: 10.1111/j.1468-1293.2010.00867.x
关键词
clinical trials; gender; highly active antiretroviral therapy; HIV infection; race; sexual orientation
资金
- University of North Carolina (UNC) Center for AIDS Research (CFAR) HIV/AIDS clinical cohort
- University of North Carolina at Chapel Hill, Center for AIDS Research, National Institutes of Health [P30 AI50410]
- University of North Carolina, General Clinical Research Center, National Institutes of Health [RR00046]
- University of North Carolina, AIDS Clinical Trials Group, National Institutes of Health [AI 69423]
Background In the USA, women, racial/ethnic minorities and persons who acquire HIV infection through heterosexual intercourse represent an increasing proportion of HIV-infected persons, and yet are frequently underrepresented in clinical trials. We assessed the demographic predictors of trial participation in antiretroviral-naive patients. Methods Patients were characterized as trial participants if highly active antiretroviral therapy (HAART) was initiated within a clinical trial. Prevalence ratios (PRs) were obtained using binomial regression. Results Between 1996 and 2006, 30% of 738 treatment-naive patients initiated HAART in a clinical trial. Trial participation rates for men who have sex with men (MSM), heterosexual men, and women were respectively 36.5, 29.6 and 24.3%. After adjustment for other factors, heterosexual men appeared less likely to participate in trials compared with MSM [PR 0.79, 95% confidence interval (CI) 0.57, 1.11], while women were as likely to participate as MSM (PR 0.97, 95% CI 0.68, 1.39). The participation rate in Black patients (25.9%) was lower compared with non-Black patients (37.5%) (adjusted PR 0.80, 95% CI 0.60, 1.06). Conclusions In our clinical setting, gender did not appear to impact participation in HIV treatment trials, but Black patients were slightly less likely to participate in these trials. Considering the substantial proportion of HIV-infected patients who are Black, future trials need to consider strategies to incorporate such underrepresented populations.
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