Porter Brian O, Anthony Kara B, Shen Jean, Hahn Barbara, Keh Chris E, Maldarelli Frank, Blackwelder William C, Lane Henry Clifford, Kovacs Joseph A, Davey Richard T, Sereti Irini
National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, Maryland 20982, USA.
AIDS. 2009 Jan 14;23(2):203-12. doi: 10.1097/QAD.0b013e32831cc114.
To evaluate whether interleukin (IL)-2 in patients with chronic HIV infection can maintain CD4 T cell counts during 6 months of HAART interruption.
Prospective, randomized, controlled, open-label phase II noninferiority trial comparing IL-2 with HAART interruption or continuous HAART.
Forty-one IL-2-experienced (three or more prior cycles) HIV-1-infected adults with CD4 cell count at least 500 cells/microl were randomized in the ratio 2: 1 to interrupted (I = 27) or continuous (C = 14) HAART for 6 months following an initial IL-2 cycle. Subsequent IL-2 cycles were triggered by CD4 T cell counts less than 90% of baseline. Immune, metabolic, and quality of life indices were compared (Mann-Whitney and Fisher's exact tests), defining noninferiority as a percentage difference (C- I) in treatment success (CD4 T cells > or =90% of baseline at 6 months) with a 95% confidence interval (CI) lower limit greater than -20%.
Demographic and immune parameters were similar between the groups at baseline. Median CD4 T cell count, HIV viral load, and treatment success differed significantly at 6 months (I: 866 cells/microl, 39,389 copies/ml, 48.1%; C: 1246 cells/microl, <50 copies/ml, 92.3%; P < or = 0.001). Group I was inferior to C (% difference = -44.2%; 95% CI: -64.2%, -11.2%; P = 0.013). Minor statistically significant differences in HgbA1c and energy level occurred at 6 months (I > C). Following HAART interruption, single cases of acute retroviral syndrome, secondary syphilis, non-Hodgkin's lymphoma, and Kaposi's sarcoma recurrence were observed.
IL-2 alone was inferior to IL-2 with HAART in maintaining baseline CD4 T cell counts. HAART interruption had a small impact on metabolic parameters and quality of life.
评估慢性HIV感染患者体内的白细胞介素（IL）-2在停止高效抗逆转录病毒治疗（HAART）6个月期间能否维持CD4 T细胞计数。
一项前瞻性、随机、对照、开放标签的II期非劣效性试验，比较IL-2与停止HAART或持续HAART的效果。
41名有IL-2治疗经验（之前接受过三个或更多疗程）、CD4细胞计数至少为500个/微升的HIV-1感染成人，按照2:1的比例随机分为两组，在初始IL-2疗程后，一组接受6个月的间断HAART（I组 = 27例），另一组接受持续HAART（C组 = 14例）。后续的IL-2疗程由CD4 T细胞计数低于基线的90%触发。比较免疫、代谢和生活质量指标（曼-惠特尼检验和费舍尔精确检验），将非劣效性定义为治疗成功率（6个月时CD4 T细胞>或 =基线的90%）的百分比差异（C - I），其95%置信区间（CI）下限大于-20%。
两组在基线时的人口统计学和免疫参数相似。6个月时，两组的CD4 T细胞计数中位数、HIV病毒载量和治疗成功率有显著差异（I组：866个/微升，39389拷贝/毫升，48.1%；C组：1246个/微升，<50拷贝/毫升，92.3%；P≤0.001）。I组劣于C组（百分比差异 = -44.2%；95%CI：-64.2%，-11.2%；P = 0.013）。6个月时，糖化血红蛋白（HgbA1c）和能量水平有微小的统计学显著差异（I组>C组）。停止HAART后，观察到单例急性逆转录病毒综合征、二期梅毒、非霍奇金淋巴瘤和卡波西肉瘤复发。
单独使用IL-2在维持基线CD4 T细胞计数方面不如IL-2联合HAART。停止HAART对代谢参数和生活质量有轻微影响。
