A prospective trial of structured treatment interruptions in human immunodeficiency virus infection
A prospective trial of structured treatment interruptions in human immunodeficiency virus infection
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DOI：
10.1001/archinte.163.10.1220
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发表时间：
2003-05-26
影响因子：
--
通讯作者：
Hirschel, B
中科院分区：
文献类型：
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作者：
Fagard, C;Oxenius, A;Hirschel, B
背景：根据“自身疫苗接种假说”，在治疗中断期间再次暴露于人类免疫缺陷病毒（HIV）可能会刺激HIV特异性免疫反应，并导致高活性抗逆转录病毒治疗（HAART）停止后出现低病毒血症。许多比目前推荐的更早开始HAART治疗的患者希望停止治疗，但尚不清楚这样做是否安全。目的：确定反复中断HAART治疗是否(1)刺激了细胞毒性hiv特异性免疫反应，以及这种刺激是否与低病毒血症治疗相关，以及(2)在临床并发症、病毒耐药性的发展和CD4细胞计数下降方面是安全的。设计：介入研究，前后比较。地点：瑞士和西班牙大学医院门诊。患者：共有133名患者接受HAART治疗，CD4细胞计数中位数为740/muL，病毒载量中位数为21个月未检测到。干预措施：HAART中断2周，重新开始，并持续8周。4个周期后，研究开始后40周无限期暂停治疗。主要观察指标：通过干扰素γ酶联免疫斑点分析评估hiv特异性细胞毒性t细胞反应。应答者（病毒载量）的比例
Background: According to the "autovaccination hypothesis," reexposure to human immunodeficiency virus (HIV) during treatment interruptions may stimulate the HIV-specific immune response and lead to low viremia after withdrawal of highly active antiretroviral treatment (HAART). Many patients who started HAART earlier in their disease course than is currently recommended would like to discontinue, but it is unknown whether it is safe to do so.Objectives: To determine whether repeated treatment interruptions of HAART (1) stimulated the cytotoxic HIV-specific immune response and whether such stimulation correlated with low viremia off treatment, and (2) were safe with respect to clinical complications, development of viral resistance, and decline in CD4 cell counts.Design: Interventional study with before-after comparison.Setting: Outpatient clinics of university hospitals in Switzerland and Spain.Patients: A total of 133 patients receiving HAART, with a median CD4 cell count of 740/muL, and whose viral load had been undetectable for a median of 21 months.Interventions: HAART was interrupted for 2 weeks, restarted, and continued for 8 weeks. After 4 such cycles, treatment was indefinitely suspended 40 weeks after study entry.Main Outcome Measures: HIV-specific cytotoxic T-cell responses were evaluated by interferon gamma enzymelinked immunospot analysis. The proportion of "responders" (viral load