AMBISOME WITH CONVENTIONAL AMPHOTERICIN B FOR INDUCTION THERAPY OF HISTOPLASMOSIS

Ambisome 与传统两性霉素 B 联合用于组织胞浆菌病的诱导治疗

• 批准号: 6117820
• 负责人: MITCHELL GOLDMAN
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6117820
• 关键词: AIDS; amphotericin B; antifungal agents; blood chemistry; clinical research; clinical trials; drug screening /evaluation; histoplasmosis; human subject; human therapy evaluation; microorganism culture

Seventy-five patients with AIDS and moderate to severe disseminated histoplasmosis will be studied. It is anticipated that 60 of these patients will be blood culture positive. Those patients who are enrolled with blood cultures which subsequently prove negative, but with other evidence of disease will be evaluated for clinical response and safety only. Patients will be randomized upon enrollment in a 2:1 ration. Administration of study drug will be conducted in a double blind fashion. Those patients randomized to receive AmBisome will receive 3.0mg/kg/d of AmBisome for a total duration of two weeks. Patients randomized to receive amphotericin B will receive a daily dose of 0.7mg/kg/ for two weeks. A 50% dose of study drug will be permitted on day 1, at the physicians discretion. Treatment with either study drug can be terminated after a minimum of seven days of therapy for a good clinical response. Study participants will be observed daily and evaluated twice weekly during the induction phase. In addition, the AmBisome treated patients will be compared witha series of historical controls.

75例中重度传播性艾滋病患者 将研究组织胞浆菌病。 预计其中60个 患者血培养阳性。 入组的患者 血培养结果为阴性，但其他 将评价疾病证据的临床反应和安全性 只. 患者将在入组时以2：1的比例随机分配。 将以双盲方式进行研究药物给药。 随机接受AmBisome的患者将接受3.0 mg/kg/d的 AmBisome共持续两周。 患者随机分配至每天 接受阿替西霉素B的患者将接受每日剂量0.7 mg/kg/两次 周 在第1天，允许使用50%剂量的研究药物， 医生的判断。 可以终止任一研究药物治疗 治疗至少7天后，临床反应良好。 将每天观察研究受试者，每周评估两次 在诱导阶段。 此外，AmBisome治疗的患者 will be compared比较with a series系列of historical历史controls控制.