Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs

Bristol-Myers Squibb0 个研究点目标入组 26,000 人开始时间: 2011年3月最近更新: 2012年12月5日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 26,000
主要终点: Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.

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: 18 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen
•Between 18-64 years of age on the index date
•At least 6 months of continuous enrollment and pharmacy benefits prior to the index date
•At least 6 months of continuous enrollment and pharmacy benefits following the index date
•At least 1 medical claim during the 6-month follow-up period

排除标准

未提供

结局指标

主要结局

Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen

时间窗: 6 months

次要结局

Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen(6 months)
Healthcare utilization(6 months)
Healthcare costs(6 months)

研究者

发起方

Bristol-Myers Squibb

申办方类型

Industry

责任方

Sponsor

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