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临床试验/NCT01455688
NCT01455688已完成4 期

Early Antiretroviral Therapy for Critically Ill HIV Infected Patients

Hospital Nossa Senhora da Conceicao1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
115
试验地点
1
主要终点
Hospital mortality

研究概览

简要总结

The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.

研究设计

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

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

  • HIV infection
  • CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age > 55 years, coinfection with HBV or HCV, neoplasia, viral load > 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness

排除标准

  • Regular use of HAART

研究组 & 干预措施

Early antiviral therapy

Experimental

干预措施: early HAART (Drug)

Conventional therapy

Active Comparator

干预措施: Late HAART (Drug)

结局指标

主要结局

Hospital mortality

时间窗: 4 weeks

It is a estimative of length of hospital stay

次要结局

  • 6-month mortality(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcio Manozzo Boniatti

Principal investigator

Hospital Nossa Senhora da Conceicao

研究点 (1)

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