Simplfied Monitoring of Antiretroviral Therapy

简化抗逆转录病毒治疗监测

• 批准号: 7900779
• 负责人: Kiat Ruxrungtham
• 金额: $ 6.23万
• 依托单位: HIV-NAT, THE THAI RED CROSS AIDS RCH CTR
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7900779
• 关键词: Adherence; Adult; Anti-Retroviral Agents; CD4 Positive T Lymphocytes; Cambodia; Caring; Cell Count; Cells; Centers for Disease Control and Prevention (U.S.); Classification; Clinic Visits; Clinical; Counseling; Disease; Frequencies; HIV; Hospitals; Immunologic Monitoring; Laboratories; Magnetism; Methods; Monitor; Opportunistic Infections; Outcome; Patients; Questionnaires; Randomized; Research; Research Infrastructure; Resources; Techniques; Testing; Thailand; Upper arm; Viral Load result; Visit; antiretroviral therapy; cost; design; follow-up; pill; programs; standard of care

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.

目标 将简化的监控方法与护理标准监控进行比较，既与密集型” 在资源有限的环境中治疗艾滋病毒疾病的依从性咨询。 评估临床访问和实验室监测的不同频率。 使用自动细胞计数的CD4细胞耗竭技术评估减少成本CD4测试 在HIV-NAT实验室开发。 具体目标 评估在资源有限设置中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护理医院以及 柬埔寨 通过咨询和问卷调查在每次诊所就诊和药丸计数中促进依从抗逆转录病毒疗法。 用自动细胞计数器验证简化磁CD4细胞的技术并评估可行性 包括柬埔寨在内的泰国地区医院的实施。 方法 该研究将在泰国和柬埔寨的初级和二级护理医院进行。九 CD4 <200细胞/mm 3或CDC临床 没有主动机会感染的分类B或C将在2 x 2阶乘中同样随机分组 设计为四个组的CD4和临床结果监测，或CD4和临床结果加上 病毒载荷，每8周或每16周进行一次随访。每只手臂中的患者将收到相同的 抗逆转录病毒疗法。临床和免疫学监测将每8周或每16周进行一次 通过随机分配的几周，将每16周进行一次病毒学监测。 主要终点 主要终点是研究第144周，患有CD4> 200细胞/mm 3的患者的比例。