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

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。这是一项 II 期开放标签随机研究，对象是已确诊或疑似患有艾滋病的受试者。这项研究的目的是了解对于患有艾滋病和大脑感染（称为隐球菌性脑膜炎）的患者同时服用两性霉素 B 和氟康唑药物是否安全，甚至是否更好。隐球菌性脑膜炎是一种真菌感染，是艾滋病患者常见的并发症。通常，隐球菌性脑膜炎的治疗方法是首先单独给予两性霉素 B，然后单独给予氟康唑。这项研究将探讨与标准治疗相比，如果研究对象同时服用两种药物 2 周，然后服用氟康唑 8 周，是否会恢复得更快，副作用也更少。 本研究将分为 3 个组，最多招募 150 名受试者，以确定 120 名可评估受试者（每组 40 名）。标准治疗组包括每天 0.7 毫克/公斤的两性霉素 B，持续 14 天，然后每天服用氟康唑 400 毫克，持续 8 周。两 (2) 个研究治疗组将包括每日两性霉素 B 0.7 mg/kg 和前 14 天随机剂量的氟康唑 400 mg/天或 800 mg/天，然后分别随机剂量 400 mg/天或 800 mg/天的氟康唑进行额外的治疗。

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