Pett S L, Wand H, Law M G, Arduino R, Lopez J C, Knysz B, Pereira L C, Pollack S, Reiss P, Tambussi G
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia.
HIV Clin Trials. 2006 Mar-Apr;7(2):70-85. doi: 10.1310/4733-acqf-f3p4-2qac.
ESPRIT, is a phase III, open-label, randomized, international clinical trial evaluating the effects of subcutaneous recombinant interleukin-2 (rIL-2) plus antiretroviral therapy (ART) versus ART alone on HIV-disease progression and death in HIV-1-infected individuals with CD4+ T-cells > or =300 cells/microL.
To describe the baseline characteristics of participants randomized to ESPRIT overall and by geographic location.
Baseline characteristics of randomized participants were summarized by region.
4,150 patients were enrolled in ESPRIT from 254 sites in 25 countries. 41%, 27%, 16%, 11%, and 5% were enrolled in Europe, North America, South America, Asia, and Australia, respectively. The median age was 40 years, 81% were men, and 76%, 11%, and 9% were Caucasian, Asian, and African American or African, respectively. 44% of women enrolled (n = 769) were enrolled in Thailand and Argentina. Overall, 55% and 38% of the cohort acquired HIV through male homosexual and heterosexual contact, respectively. 25% had a prior history of AIDS-defining illness; Pneumocystis jirovecii pneumonia, M. tuberculosis, and esophageal candida were most commonly reported. Median nadir and baseline CD4+ T-cell counts were 199 and 458 cells/muL, respectively. 6% and 13% were hepatitis B or C virus coinfected, respectively. Median duration of antiretroviral therapy (ART) was 4.2 years; the longest median duration was in Australia (5.2 years) and the shortest was in Asia (2.3 years). 17%, 13%, and 69% of participants began ART before 1995, between 1996 and 1997, and from 1998 onward, respectively. 86% used ART from two or more ART classes, with 49% using a protease inhibitor-based regimen and 46% using a nonnucleoside reverse transcriptase inhibitor-based regimen. 78% had plasma HIV RNA below detection (<500 cp/mL).
ESPRIT has enrolled a diverse population of HIV-infected individuals including large populations of women and patients of African-American/African and Asian ethnicity often underrepresented in HIV research. As a consequence, the results of the study may have wide global applicability.
ESPRIT是一项III期、开放标签、随机、国际临床试验，旨在评估皮下注射重组白细胞介素-2（rIL-2）加抗逆转录病毒疗法（ART）与单纯ART相比，对CD4+T细胞≥300个/微升的HIV-1感染者的HIV疾病进展和死亡的影响。
描述总体上以及按地理位置随机分组到ESPRIT研究中的参与者的基线特征。
按地区总结随机分组参与者的基线特征。
ESPRIT研究从25个国家的254个地点招募了4150名患者。分别有41%、27%、16%、11%和5%的患者来自欧洲、北美、南美、亚洲和澳大利亚。中位年龄为40岁，81%为男性，分别有76%、11%和9%为白种人、亚洲人以及非裔美国人或非洲人。入组的女性患者（n = 769）中有44%来自泰国和阿根廷。总体而言，队列中分别有55%和38%的人通过男性同性恋和异性接触感染HIV。25%的人有过艾滋病定义疾病史；最常报告的是耶氏肺孢子菌肺炎、结核分枝杆菌感染和食管念珠菌病。CD4+T细胞计数的中位最低点和基线分别为199个/微升和458个/微升。分别有6%和13%的人合并感染乙型或丙型肝炎病毒。抗逆转录病毒疗法（ART）的中位疗程为4.2年；最长的中位疗程在澳大利亚（5.2年），最短的在亚洲（2.3年）。分别有17%、13%和69%的参与者在1995年之前、1996年至1997年之间以及1998年以后开始接受ART治疗。86%的人使用了两种或更多类别的ART药物，其中49%使用基于蛋白酶抑制剂的方案，46%使用基于非核苷类逆转录酶抑制剂的方案。78%的人的血浆HIV RNA低于检测下限（<500拷贝/毫升）。
ESPRIT研究招募了多样化的HIV感染者群体，包括大量女性以及在HIV研究中经常代表性不足的非裔美国/非洲和亚洲族裔患者。因此，该研究结果可能具有广泛的全球适用性。
