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临床试验/NCT00543530
NCT00543530已完成3 期

A Noncomparative,Open, Multisite Study to Monitor the Safety and Tolerability of Efavirenz Oral Solution Given in Combination Antiretroviral Therapy (ART) in ART-naive or Experienced HIV-1 Infected Patients Age 3 to 16 Years Who Have Failed Therapy or Are Intorerant to Their Current ART Regimen

Merck Sharp & Dohme LLC0 个研究点开始时间: 2001年3月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成

研究概览

简要总结

Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Not tolerating current ART regime laboratory status is stable
  • Able to take oral liquid medications but have difficulty swallowing capsules
  • Weigh at least 10 kg (22 lbs)

排除标准

  • Has had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to taking study drug
  • Have taken another investigational drug 30 days before starting this study
  • Have a history of drug or alcohol abuse

研究者

申办方类型
Industry
责任方
Sponsor

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