BAMSG 3-01

BAMSG 3-01

• 批准号: 7380473
• 负责人: Peter George Pappas
• 金额: $ 6.51万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380473
• 关键词: BAMSG; 01

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will look at whether study participants recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. Participants will be followed for 6 months from the time they are enrolled into the study. Primary Obiective(s): 1. To assess the safety and tolerability of the study drug regimens. 2. To determine whether the safety and efficacy of combination therapy supports development of a phase III trial of combination therapy, and if so, to select the most appropriate dose of fluconazole plus amphotericin B based on safety and efficacy to be evaluated in a subsequent phase III trial. Secondary Objective(s): 1. To compare the efficacy of the study drug treatments at 2, 6, and 10 weeks (Days 14,42, and 70). 2. To compare the findings on detailed neurological examination between study arms at baseline and 2, 6, and 10 weeks, and 24 weeks (6 months). 3. To assess the proportion of subjects in each study arm that are alive at 6 months after initiation of study therapy. 4. To describe the effects of baseline clinical, neurological, and mycological characteristics on mycological failure at 2 and 10 weeks. 5. To measure time to CSF culture-negativity for each study arm. 6. To assess the length of hospitalization in the treatment groups as a surrogate of cost efficiency. 7. To assess the incidence of immune reconstitution inflammatory syndrome (IRIS) among all subjects receiving highly active antiretroviral therapy (HAART). 8. To examine antifunqal susceptibility of all clinical isolate

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。这项研究将检查隐球菌脑膜炎的联合治疗的有效性和安全性，隐球菌脑膜炎是一种在发展中国家获得性免疫缺陷综合征（AIDS）患者中常见的真菌感染。标准的初始治疗包括两种药物：阿替霉素B治疗2周，然后是氟康唑治疗8周。这项研究将研究与标准治疗相比，如果研究参与者同时服用两种药物2周，然后服用氟康唑8周，他们是否恢复得更快，副作用更少。受试者将从入组研究时起接受6个月的随访。主要目的：1.评估研究药物方案的安全性和耐受性。2.确定联合治疗的安全性和有效性是否支持开展联合治疗的III期试验，如果支持，则根据安全性和有效性选择最合适的氟康唑联合阿替霉素B剂量，以在随后的III期试验中进行评价。次要目标：1。比较研究药物治疗在第2、6和10周（第14、42和70天）的疗效。2.比较研究组在基线和第2、6和10周以及第24周（6个月）时的详细神经系统检查结果。3.评估每个研究组中研究治疗开始后6个月时存活的受试者比例。4.描述基线临床、神经学和真菌学特征对2周和10周真菌学失败的影响。5.测量每个研究组至CSF培养阴性的时间。评估治疗组的住院时间作为成本效率的替代。7.评估所有接受高效抗逆转录病毒治疗（HAART）的受试者中免疫重建炎症综合征（IRIS）的发生率。8.检测所有临床分离菌株的药物敏感性