NCT00002032已完成不适用
Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
Pharmacia62 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 62
研究概览
简要总结
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the following:
- •Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
- •Written informed consent.
- •Females of childbearing potential must also sign a special informed consent.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
- •Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.
- •Concurrent Medication:
- •Antiretroviral agents other than zidovudine (AZT).
- •Didanosine (ddI).
- •Antimycobacterial therapy.
- •Rifampin.
- •Isoniazid.
- •Clofazimine.
- •Ethambutol.
- •Cycloserine.
- •Ethionamide.
- •Amikacin.
- •Ciprofloxacin.
- •Streptomycin.
- •Other investigational drugs.
- •If antimicrobial therapy is required to treat bacterial infections (= or < 14 days), Adria Laboratories must be contacted prior to initiation of therapy.
- •Patients with the following are excluded:
- •Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
- •Previous or current Mycobacterium avium complex (MAC) infection.
- •Perceived patient unreliability or unavailability for frequent monitoring.
- •Prior Medication:
- •Excluded within 4 weeks of study entry:
- •Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
- •Antimycobacterial therapy.
- •Rifampin.
- •Isoniazid.
- •Clofazimine.
- •Ethambutol.
- •Cycloserine.
- •Ethionamide.
- •Amikacin.
- •Ciprofloxacin.
- •Zidovudine (AZT).
- •Antipneumocystis prophylactic therapy.
- •Required for at least 4 weeks prior to study entry:
- •Zidovudine (AZT) or didanosine (ddI).
- •Antipneumocystis prophylaxis.
研究者
研究点 (62)
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