跳至主要内容
临床试验/NCT00002446
NCT00002446已完成3 期

Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

Schering-Plough36 个研究点 分布在 2 个国家目标入组 300 人开始时间: 1998年8月1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
300
试验地点
36

研究概览

简要总结

The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.

详细描述

Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • You may be eligible for this study if you:
  • Are at least 18 years old.
  • Are HIV-positive.
  • Have thrush (oropharyngeal candidiasis).
  • Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
  • Are able to take study medication and return for clinic visits during the study.
  • Are expected to live for at least 2 months.

排除标准

  • You will not be eligible for this study if you:
  • Have received protease inhibitors for the first time within 30 days prior to study entry.
  • Have received certain medications.
  • Have certain other types of fungal infections.
  • Have certain types of cancer.
  • Have received SCH 56592 within 3 months prior to study entry.
  • Are pregnant or breast-feeding.
  • Cannot take medications by mouth.
  • Are allergic to azole drugs.
  • Have certain medical conditions.
  • Have been in this study before.

研究者

发起方
Schering-Plough
申办方类型
Industry

研究点 (36)

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