Simplified Monitoring of Antiretroviral Therapy

目标 比较简化监测方法与标准护理监测，两者均与强化监测相结合。 在资源有限的情况下治疗艾滋病毒疾病的依从性咨询。 评价不同频率的临床访视和实验室监测。 目的：评价CD 4细胞去除联合自动细胞计数技术降低CD 4检测成本的效果 在HIV-NAT实验室开发的。 具体目标 评价在资源有限的情况下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立艾滋病毒监测的基础设施和能力， 柬埔寨 通过咨询和在每次诊所就诊时进行问卷调查以及计算药丸数量，促进抗逆转录病毒治疗的坚持。 验证自动细胞计数仪简易磁性CD 4细胞去除技术，评估其可行性 在包括柬埔寨在内的泰国地区医院实施。 方法 该研究将在泰国和柬埔寨的初级和二级保健医院进行。九 32例CD 4 <200个细胞/mm 3或CDC临床的抗逆转录病毒初治HIV感染成人 无活动性机会性感染的分类B或C将在2 x 2析因中随机分配 设计为四组，通过CD 4和临床结局或CD 4和临床结局+ 病毒载量，并每8周或每16周随访一次。每组患者将接受相同的 抗逆转录病毒疗法每8周或每16周进行一次临床和免疫学监测 每16周进行一次病毒学监测。 主要终点 主要终点是在研究的第144周具有CD 4>200个细胞/mm 3的患者的比例。

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.