NCT00002140已完成3 期
A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 24
研究概览
简要总结
To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..
详细描述
Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.
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
- •Patients must have:
- •HIV seropositivity.
- •Disseminated MAC.
- •No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
- •Life expectancy of at least 2 months.
- •Consent of parent or guardian if below legal age of consent.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
- •Inability to take oral medications.
- •Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).
- •Concurrent Medication:
- •Another investigational drug started in the week prior to study entry.
- •Prior Medication:
- •MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
研究者
研究点 (24)
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