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AMBISOME WITH CONVENTIONAL AMPHOTERICIN B FOR INDUCTION THERAPY OF HISTOPLASMOSIS

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
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

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项目成果

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中文摘要
翻译
75例艾滋病和中至重度播散性疾病 将对组织胞浆菌病进行研究。预计其中60个 患者的血培养将呈阳性。那些入选的患者 血液培养结果为阴性,但其他 将对疾病的证据进行临床反应和安全性评估 只有这样。患者将在登记时按2:1的比例随机进行。 研究用药实行双盲管理。 那些随机接受AmBisome治疗的患者将接受3.0 mg/kg/d的 AmBisome,为期两周。患者被随机分配到 接受两性霉素B将获得0.7毫克/公斤/两人每日剂量 几周。50%剂量的研究药物将被允许在第一天,在 医生的判断力。使用任何一种研究药物的治疗都可以终止 经过至少七天的治疗,取得良好的临床疗效。 研究参与者将每天接受观察,每周评估两次 在诱导阶段。此外,AmBisome治疗的患者 将与一系列历史控制进行比较。
英文摘要
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.
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