NCT00002282已完成不适用
A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
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
- 17
研究概览
简要总结
To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
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
- •Concurrent Medication:
- •Cimetidine.
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- •Moderate or severe liver disease defined by specified lab values.
- •Concurrent Medication:
- •Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
- •Barbiturates.
- •Phenytoin.
- •Coumarin-type anticoagulants.
- •Rifampin.
- •Oral hypoglycemics.
- •Cyclosporin.
- •Patients with the following are excluded:
- •Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
- •Unable to tolerate oral medication.
- •Moderate or severe liver disease defined by specified lab values.
- •Life expectancy < 4 weeks.
- •Unable or unwilling to be followed at the same center for the conduct of this study.
- •Prior Medication:
- •Excluded within 3 days of study entry:
- •Other antifungal agents.
- •Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
- •Barbiturates.
- •Phenytoin.
- •Coumarin-type anticoagulants.
- •Rifampin.
- •Oral hypoglycemics.
- •Cyclosporin.
- •Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).
- •Patients who have given informed consent in writing to their participation in the study.
- •Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
研究者
研究点 (17)
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