AMPHOTERICIN B USED ALONE OR COMBINED WITH FLUCONAZOLE TO TREAT AIDS/MENINGITIS

两性霉素 B 单独使用或与氟康唑联合使用治疗艾滋病/脑膜炎

• 批准号: 7376336
• 负责人: Rodrigo Hasbun
• 金额: $ 0.4万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376336
• 关键词: AMPHOTERICIN; USED; ALONE; COMBINED; FLUCONAZOLE

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 is a Phase II open-label, randomized study in subjects with proven or presumptive AIDS. This research study is being done to learn if it is safe or maybe even better to give the drugs amphotericin B and fluconazole together at the same time to patients with AIDS and an infection in their brain called cryptococcal meningitis. Cryptococcal meningitis is a fungal infection and is a common complication in patients with AIDS. Usually cryptococcal meningitis is treated by first giving amphotericin B alone and then fluconazole alone. This study will look at whether study subjects 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. There will be 3 arms in this study enrolling a maximum of 150 subjects to identify 120 evaluable subjects (40 per arm). The standard therapy arm will include amphotericin B 0.7 mg/kg per day for 14 days followed by fluconazole 400 mg daily for 8 weeks. The two (2) investigational treatment arms will include daily amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day or 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day or 800 mg/day respectively for an additional

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这是一项针对已确诊或推定为艾滋病的受试者的二期开放随机研究。这项研究是为了了解两性霉素B和氟康唑同时给艾滋病患者和他们大脑中一种称为隐球菌性脑膜炎的感染的患者是否安全，或者甚至更好。隐球菌性脑膜炎是一种真菌感染，是艾滋病患者的常见并发症。通常，隐球菌性脑膜炎的治疗方法是先单用两性霉素B，然后单用氟康唑。这项研究将观察与标准治疗相比，如果研究对象同时服用两种药物2周，然后服用8周氟康唑，是否恢复得更快，副作用更少。在这项研究中，将有3个手臂，最多招募150名受试者，以确定120名可评估的受试者(每只手臂40名)。标准治疗组包括两性霉素B 0.7 mg/kg/d，连续14天，然后是氟康唑400 mg，每天400 mg，连续8周。这两(2)个研究治疗组合将包括每日0.7毫克/公斤的两性霉素B和随机剂量的氟康唑，前14天分别为400毫克/天或800毫克/天，然后随机剂量分别为400毫克/天或800毫克/天