BAMSG 3-01

BAMSG 3-01

• 批准号: 7603217
• 负责人: Peter George Pappas
• 金额: $ 8.96万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603217
• 关键词: Acquired Immunodeficiency Syndrome; Adverse effects; Amphotericin B; Characteristics; Clinical; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Cryptococcal Meningitis; Development; Dose; Effectiveness; Enrollment; Failure; Fluconazole; Funding; Grant; Highly Active Antiretroviral Therapy; Hospitalization; Immune; Incidence; Inflammatory; Institution; Length; Measures; Mycoses; Neurologic; Neurologic Examination; Participant; Persons; Pharmaceutical Preparations; Phase III Clinical Trials; Predisposition; Research; Research Personnel; Resources; Safety; Source; Standards of Weights and Measures; Syndrome; Time; Treatment Protocols; United States National Institutes of Health; Upper arm; Week; base; cost; day; reconstitution

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. Lay Summary: 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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 报告摘要：这项研究将检验联合治疗隐球菌性脑膜炎的有效性和安全性。隐球菌性脑膜炎是发展中国家获得性免疫缺陷综合征(AIDS)患者中常见的一种真菌感染。标准的初始治疗包括两种药物：两性霉素B 2周，然后是8周的氟康唑。这项研究将观察与标准治疗相比，如果研究参与者同时服用两种药物2周，然后服用8周氟康唑，他们是否恢复得更快，副作用更少。参与者将被跟踪6个月，从他们加入研究的时间开始。 初级观察者(S)： 1.评价研究用药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加两性霉素B剂量，以便在随后的III期试验中进行评估。 次要目标(S)： 1.比较研究药物治疗2、6、10周(第14、42、70天)的疗效。 2.比较研究组在基线、2周、6周、10周、24周(6个月)的详细神经学检查结果。 3.评估每个研究组中在研究治疗开始后6个月仍存活的受试者的比例。 4.描述基线临床、神经系统和真菌学的影响 2周和10周时真菌学失败的特点。 5.测量每个研究组的脑脊液培养时间。 6.评估治疗组的住院时间，作为成本效益的替代指标。 7.评估免疫重建炎症综合征(IRIS)的发生率 在所有接受高效抗逆转录病毒治疗(HAART)的受试者中。 8.检测所有临床分离株的抗真菌药物敏感性