NCT00002101已完成3 期
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
Pharmacia86 个研究点 分布在 1 个国家目标入组 450 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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 86
研究概览
简要总结
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
详细描述
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Isoniazid for TB prophylaxis ONLY.
- •Patients must have:
- •HIV infection.
- •MAC infection.
- •Life expectancy of at least 16 weeks.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Perceived unreliability or unavailability for frequent monitoring.
- •Concurrent Medication:
- •Antimycobacterial drugs other than the study drugs.
- •Carbamazepine.
- •Terfenadine.
- •Theophylline.
- •Patients with the following prior condition are excluded:
- •History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.
- •Prior Medication:
- •Excluded within 7 days prior to study entry:
- •Rifabutin.
- •Rifampin.
- •Ethionamide.
- •Cycloserine.
- •Clofazimine.
- •Ethambutol.
- •Amikacin.
- •Ciprofloxacin.
- •Ofloxacin.
- •Sparfloxacin.
- •Azithromycin.
- •Clarithromycin.
- •Pyrazinamide.
- •Excluded within 14 days prior to study entry:
- •Carbamazepine.
- •Terfenadine.
- •Theophylline.
研究者
研究点 (86)
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