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: 6291058
• 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/6291058
• 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例艾滋病患者中、重度播散