跳至主要内容
临床试验/NCT00001995
NCT00001995已完成不适用

A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Pharmacia42 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年8月31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
入组人数
200
试验地点
42

研究概览

简要总结

To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.

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

  • Concurrent Medication:
  • Zidovudine (AZT).
  • Didanosine (ddI).
  • Patients must have the following:
  • Diagnosis of AIDS as defined by the CDC.
  • Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
  • Provide written informed consent.
  • Prior Medication:
  • If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
  • Required:
  • Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.

排除标准

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Known hypersensitivity to any of the study drugs.
  • Concurrent Medication:
  • Other therapy for mycobacterial disease.
  • Patients with the following are excluded:
  • Known hypersensitivity to any of the study drugs.
  • Prior Medication:
  • Excluded within 4 weeks:
  • Therapy for mycobacterial disease.
  • Antiretroviral drugs, other than zidovudine (AZT) or ddI.
  • Investigational drugs, other than ddI.

研究者

发起方
Pharmacia
申办方类型
Industry

研究点 (42)

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