DISCONTINUING THERAPY IN SUBJECTS W/ DISSEMINATED MAC

这项研究将向所有ACTG网站开放。目前正在接受抗逆转录病毒治疗至少16周的50名受试者，以前被诊断为DMAC，使用基于大环内酯类药物的方案治疗至少12个月，并且至少16周没有MAC症状，CD4+细胞计数和GT；或等于100个/mm3，将有资格进入(步骤1)。所有受试者将在研究开始时进行外周血培养和骨髓样本(抽吸)培养，以确定是否发生了MAC的微生物灭菌。如果骨髓或血液培养呈MAC阳性，受试者将停止研究，随访生存，并接受初级保健提供者提供的标准护理。如果血液和骨髓培养是无菌的，受试者将接受6周的治疗，然后在6周停止MAC治疗进入步骤2)。根据第4.3节的规定，受试者将被监测MAC的临床症状和体征，并将进行血培养以寻找分枝杆菌。将对受试者进行监测，直到最后一名受试者学习了大约60周。预计这项研究将在大约一年内完成；因此，第一个主题的总研究时间可长达约110周。在临床怀疑复发的任何时候，都会进行外周血培养和骨髓培养。如果其中一种培养阳性或两种培养都呈阳性，受试者将由其初级卫生保健提供者酌情开始治疗，并进行跟踪，直到研究结束。这项研究不会提供治疗MAC的药物。

This study will be open to all ACTG sites. Fifty subjects currently receiving antiretroviral therapy for at least 16 weeks, who have previously been diagnosed with DMAC, treated for at least 12 months with a macrolide- based regimen, and are asymptomatic for MAC for at least 16 weeks with CD4+ counts > or equal to 100 cells/mm3 will be eligible for entry (Step 1). All subjects will have peripheral blood cultures and a bone marrow sample (aspirate) culture performed at study entry to determine if microbiologic sterilization of MAC has occurred. If either bone marrow or blood cultures are positive for MAC, the subject will be discontinued from study, followed for survival, and receive standard of care provided by their primary care provider. If the blood and bone marrow cultures are sterile, subjects will receive 6 weeks of treatment, then discontinued MAC therapy at Week 6 entry into Step 2). Subjects will be monitored for clinical signs and symptoms of MAC and blood culture for mycobacterial will be performed according to Section 4.3. Subjects will be monitored until the last subject enrolled has been on study for approximately 60 weeks. It is anticipated that the study will accrue in approximately one year; therefore, the total duration on study for the first subject can be up to approximately 110 weeks. Peripheral blood cultures and bone marrow cultures will be obtained at any time where clinical suspicion of recurrence exists. If either or both cultures are positive, the subject will have treatment initiated at the discretion of their primary health care provider and be followed until study closure. The drugs for MAC treatment will not be provided by the study.