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，不一定是研究者所在机构。这是一项II期、开放标签、随机化研究，受试者为已证实或推定的艾滋病患者。这项研究的目的是为了了解同时给予艾滋病和隐球菌性脑膜炎患者药物阿替西汀B和氟康唑是否安全，或者可能更好。隐球菌脑膜炎是一种真菌感染，是艾滋病患者的常见并发症。通常隐球菌脑膜炎的治疗首先是单用阿替霉素B，然后单用氟康唑。这项研究将观察与标准治疗相比，如果研究受试者同时给予两种药物2周，然后给予氟康唑8周，是否恢复更快，副作用更少。 本研究将有3个组，最多入组150例受试者，以确定120例可评价受试者（每组40例）。标准治疗组将包括阿替霉素B 0.7 mg/kg/天，持续14天，随后氟康唑400 mg/天，持续8周。两（2）个试验性治疗组将包括每日0.7 mg/kg阿替霉素B和随机剂量400 mg/天或800 mg/天的氟康唑，持续前14天，然后分别随机剂量400 mg/天或800 mg/天的氟康唑，持续另外14天。

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