NCT00002331已完成不适用
A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS
Abbott18 个研究点 分布在 2 个国家开始时间: 1994年1月1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
- 试验地点
- 18
研究概览
简要总结
PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).
SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •History of HIV seropositivity.
- •Disseminated MAC.
- •Positive blood culture for MAC within 4 weeks prior to study entry.
- •Consent of parent or guardian if less than 18 years of age.
- •Ability to complete the study.
- •Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.
排除标准
- •Concurrent Medication:
- •Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
- •Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
- •Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
- •Amikacin.
- •Azithromycin.
- •Capreomycin.
- •Ciprofloxacin.
- •Cycloserine.
- •Ethionamide.
- •Gentamicin.
- •Kanamycin.
- •Levofloxacin.
- •Lomefloxacin.
- •Ofloxacin.
- •Rifampin.
- •Rifabutin.
- •Sparfloxacin.
- •Streptomycin.
- •Any other aminoglycosides, quinolones, and macrolides.
- •Patients with the following prior conditions are excluded:
- •History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.
- •Prior Medication:
- •Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
- •Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
研究者
研究点 (18)
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