NCT00002343已完成4 期
An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3
Pharmacia2 个研究点 分布在 1 个国家目标入组 200 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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
研究概览
简要总结
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
详细描述
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Concurrent Medication:
- •AZT, d4T, ddI, or ddC.
- •Antipneumocystis prophylaxis.
- •Short course (< 14 days) of ciprofloxacin for acute infections.
- •Patients must have:
- •CD4 count <= 100 cells/mm
- •NO prior or current MAC infection.
- •Prior Medication:
- •Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.
- •Prior rifabutin.
- •Prior ethambutol.
- •Prior clarithromycin.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Positive tuberculin skin test (PPD > 5 mm).
- •Active M. tuberculosis.
- •Perceived as unreliable or unavailable for frequent monitoring.
- •Concurrent Medication:
- •Other antiretrovirals not specifically allowed.
- •All investigational drugs.
- •Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (>= 14 days).
- •Patients with the following prior conditions are excluded:
- •Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.
- •Prior Medication:
- •Excluded within 4 weeks prior to study entry:
- •Rifampin.
- •Isoniazid.
- •Clofazimine.
- •Cycloserine.
- •Ethionamide.
- •Amikacin.
- •Ciprofloxacin.
研究者
研究点 (2)
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