早期 HIV 感染中单独使用白介素-2 或联合周期抗逆转录病毒治疗的效果：STALWART 研究。
Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.
机构信息
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
出版信息
PLoS One. 2010 Feb 23;5(2):e9334. doi: 10.1371/journal.pone.0009334.
BACKGROUND
The Study of Aldesleukin with and without antiretroviral therapy (STALWART) evaluated whether intermittent interleukin-2 (IL-2) alone or with antiretroviral therapy (ART) around IL-2 cycles increased CD4(+) counts compared to no therapy.
METHODOLOGY
Participants not on continuous ART with > or = 300 CD4(+) cells/mm(3) were randomized to: no treatment; IL-2 for 5 consecutive days every 8 weeks for 3 cycles; or the same IL-2 regimen with 10 days of ART administered around each IL-2 cycle. CD4(+) counts, HIV RNA, and HIV progression events were collected monthly.
PRINCIPAL FINDINGS
A total of 267 participants were randomized. At week 32, the mean CD4(+) count was 134 cells greater in the IL-2 alone group (p<0.001), and 133 cells greater in the IL-2 plus ART group (p<0.001) compared to the no therapy group. Twelve participants in the IL-2 groups compared to 1 participant in the group assigned to no therapy experienced an opportunistic event or died (HR 5.84, CI: 0.59 to 43.57; p = 0.009).
CONCLUSIONS
IL-2 alone or with peri-cycle HAART increases CD4(+) counts but was associated with a greater number of opportunistic events or deaths compared to no therapy. These results call into question the immunoprotective significance of IL-2-induced CD4(+) cells.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00110812.
背景
研究白细胞介素-2（IL-2）联合或不联合抗逆转录病毒治疗（STALWART）评估了间歇给予 IL-2 单独或与 IL-2 周期周围的抗逆转录病毒治疗（ART）相比，是否会增加 CD4（+）计数，而不进行治疗。
方法
未接受连续 ART 且 CD4（+）计数≥300 个/毫米 3 的参与者随机分为：无治疗；IL-2 连续 5 天，每 8 周 3 个周期；或相同的 IL-2 方案，在每个 IL-2 周期周围给予 10 天的 ART。每月收集 CD4（+）计数、HIV RNA 和 HIV 进展事件。
主要发现
共 267 名参与者被随机分配。在第 32 周时，IL-2 单独组的平均 CD4（+）计数增加了 134 个细胞（p<0.001），IL-2 加 ART 组增加了 133 个细胞（p<0.001），与无治疗组相比。与无治疗组相比，IL-2 组有 12 名参与者发生机会性感染或死亡，而分配到无治疗组的有 1 名参与者（HR 5.84，CI：0.59 至 43.57；p = 0.009）。
结论
IL-2 单独或与周期周围的 HAART 均可增加 CD4（+）计数，但与无治疗相比，发生机会性感染或死亡的人数更多。这些结果对 IL-2 诱导的 CD4（+）细胞的免疫保护意义提出了质疑。
试验注册
ClinicalTrials.gov NCT00110812。
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