Simplified Monitoring of Antiretroviral Therapy

目标 将简化监测方法与标准护理监测方法进行比较，两者结合使用 坚持咨询，在资源有限的情况下治疗艾滋病毒疾病。 评价不同的临床就诊频率和实验室监测频率。 应用CD_4细胞耗竭技术和自动细胞计数技术评价低成本的CD_4检测 在HIV-NAT实验室开发的。 具体目标 在资源有限的情况下评估接受抗逆转录病毒治疗的患者的简化监测 在泰国的初级和二级保健医院建设艾滋病毒监测的基础设施和能力 柬埔寨 通过咨询和问卷调查，在每次门诊和清点药片时促进对抗逆转录病毒治疗的坚持。 应用全自动细胞计数器验证简化磁性CD4细胞耗竭技术的可行性 在包括柬埔寨在内的泰国地区医院实施。 方法 这项研究将在泰国和柬埔寨的初级和二级保健医院进行。九 123例抗逆转录病毒感染的成人HIV感染者的CD4和200细胞/m3或CDC临床试验 没有活动性机会性感染的B级或C级将按2 x 2因子平均随机分配 设计为四组，通过CD4和临床结果或CD4和临床结果加进行监测 病毒载量，每8周或每16周随访一次。每个手臂的患者都将得到相同的 抗逆转录病毒治疗。每8周或每16周进行一次临床和免疫学监测 随机分配周，病毒学监测每16周进行一次。 主端点 主要终点是在研究第144周时CD4&GT；200细胞/立方米的患者所占比例。

Objectives To compare simplified monitoring methods to standard of care monitoring, both in combination with intensive adherence counselling, in the treatment of HIV disease in resource limited settings. To evaluate the different frequency of clinical visit and laboratory monitoring. To evaluate the reduced-cost CD4 testing using the technique of CD4 cell depletion with automated cell counting developed at the HIV-NAT laboratory. Specific aims To evaluate simplified monitoring in patients treated with antiretroviral therapy in resource limited settings To build infrastructure and capacity for HIV monitoring in primary and secondary care hospitals in Thailand and Cambodia To promote adherence to antiretroviral therapy by counselling and questionnaire at every clinic visit and pill counts. To validate the technique of simplified magnetic CD4 cells depletion with automated cell counter and assess feasibility of implementation at regional hospitals in Thailand including Cambodia. Methods The study will be conducted in primary and secondary care hospitals in Thailand and Cambodia. Nine hundred thirty-two antiretroviral na'fve HIV-infected adults with CD4 <200 cells/mm 3 or CDC clinical classification B or C without active opportunistic infections will be equally randomized in a 2 x 2 factorial design to four groups to be monitored by either CD4 and clinical outcome, or CD4 and clinical outcome plus viral load, and followed-up every 8 weeks or every 16 weeks. Patients in each arm will receive the same antiretroviral therapy. Clinical and immunological monitoring will be performed every 8 weeks or every 16 weeks assigned by randomization, and virological monitoring will be performed every 16 weeks. Primary endpoint Primary endpoint is the proportion of patient with CD4 >200 cells/mm 3 at week 144 of study.