跳至主要内容
临床试验/NCT02211807
NCT02211807已完成不适用

The Risk of Suicidality and Suicide Attempt Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens

Bristol-Myers Squibb0 个研究点目标入组 11,400 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11,400
主要终点
Number of cases of Suicidality, defined as suicidal ideation and suicide attempt

研究概览

简要总结

The purpose of this study was to compare the frequency of suicidality and suicide attempt among HIV patients starting treatment with Efavirenz and with patients starting treatment with other HIV medications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 6 months of enrollment before first prescription
  • Antiretroviral naive

排除标准

  • No diagnosis of HIV on patient record
  • Age < 12 years

结局指标

主要结局

Number of cases of Suicidality, defined as suicidal ideation and suicide attempt

时间窗: Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period

次要结局

  • Number of suicide attempt cases, defined as an inpatient or emergency room claim with at least one ICD-9-CM code for suicide attempt(Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period)
  • Number of suicide attempt cases(Patients will be followed from date of index fill of efavirenz or comparator antiretrovirals until earliest of date of suicidality claim,30th day after the last day of the days supply of the index medication,last day of enrollment or end of study period)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

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