NCT00002090已完成不适用
An Open, Multicenter, Randomized, Dose-Ranging Study of Azithromycin in the Treatment of Disseminated Mycobacterium Avium-Intracellulare Complex Infection (MAC) in Patients With Acquired Immune Deficiency Syndrome (AIDS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 6
研究概览
简要总结
To evaluate the efficacy and safety of two doses of azithromycin given chronically for the treatment of Mycobacterium avium bacteremia in AIDS patients.
研究设计
- 研究类型
- Interventional
- 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:
- •Medications allowed under a Treatment IND program.
- •Patients must have:
- •HIV infection.
- •Disseminated Mycobacterium avium Complex.
- •Fever (> 100 degrees F) that cannot be attributed to another active infection, and at least one other constitutional symptom (such as fatigue, malaise, anorexia).
- •Life expectancy of at least the duration of the study.
- •Consent of parent or guardian if below the legal age of consent.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Known hypersensitivity or significant intolerance to macrolide antibiotics.
- •Inability to take oral medications or a current condition likely to interfere with drug absorption (e.g., gastrectomy).
- •Prior Medication:
- •Treatment with an immunostimulant or immunomodulator compound such as alpha-interferon, gamma-interferon, or any interleukin within 7 days prior to study entry.
- •Any other antibiotic with known activity against M. avium within 7 days prior to study entry.
- •Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
研究者
研究点 (6)
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