DISCONTINUING THERAPY IN SUBJECTS W/ DISSEMINATED MAC

患有播散性 MAC 的受试者停止治疗

• 批准号: 6265139
• 负责人: MITCHELL GOLDMAN
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265139
• 关键词: AIDS therapy; HIV infections; Mycobacterium avium; Mycobacterium intracellulare; chemoprevention; clinical research; clinical trial phase I; combination chemotherapy; human subject; human therapy evaluation; microorganism disease chemotherapy; opportunistic infections

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.

本研究将对所有ACTG研究中心开放。 目前接受抗逆转录病毒治疗至少16周的50名受试者将有资格进入（步骤1），所述受试者先前已被诊断患有DMAC，用基于大环内酯的方案治疗至少12个月，并且对于MAC无症状至少16周，CD 4+计数>或等于100个细胞/mm 3。 所有受试者将在研究入组时进行外周血培养和骨髓样本（抽吸物）培养，以确定MAC是否发生微生物灭菌。 如果骨髓或血液培养结果为MAC阳性，则受试者将退出研究，随访生存情况，并接受其初级保健提供者提供的标准治疗。 如果血液和骨髓培养物无菌，则受试者将接受6周治疗，然后在第6周停止MAC治疗，进入步骤2）。 将监测受试者的MAC临床体征和症状，并根据第4.3节进行分枝杆菌血培养。 将对受试者进行监测，直至入组的最后一例受试者参与研究约60周。 预计研究将在约1年内累积;因此，首例受试者的研究总持续时间可长达约110周。 在临床怀疑存在复发的任何时间，将获得外周血培养和骨髓培养。 如果一种或两种培养物均为阳性，则受试者将由其初级卫生保健提供者酌情决定是否开始治疗，并随访至研究结束。 本研究不提供MAC治疗药物。