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临床试验/NCT00615563
NCT00615563已完成不适用

Utilization of HIV Drug Resistance Testing in Treatment Experienced Patients (UTILIZE Study)

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
246
试验地点
1
主要终点
Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).

研究概览

简要总结

The primary objective of this trial was to assess the presence of susceptibility to tipranavir and other ARVs of the HIV-1 isolates in treatment experienced patients. The secondary objective was to examine clinicians' use of HIV drug resistance testing in treatment experienced patients currently failing a PI based HAART regimen.

研究设计

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

入排标准

年龄范围
18 Years 至 18 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Levels of sensitivity of a patient's HIV-1 isolate to other marketed ARVs (PIs, NRTIs, and NNRTIs).

时间窗: Day 1

Level of sensitivity of a patient's HIV-1 isolate to tipranavir

时间窗: Day 1

次要结局

  • Relationship between prior number of PIs utilized and number of available (sensitive) PIs as determined by resistance testing(up to 45 days)
  • Rationale reported for modifying or not modifying baseline ARV regimen after receiving resistance testing results(up to 45 days)
  • Utilization (yes/no) of expert interpretation by a clinician after receiving resistance testing results(up to 45 days)
  • The physician's assessment of whether the phenotypic testing (as part of combined testing) provided more information than the genotypic test alone did(up to 45 days)
  • Protease inhibitor(s) (PI) identified by the clinician prior to resistance testing to which a patient's HIV-1 virus was thought to be susceptible(Day 1)
  • PI that was discontinued or initiated after receiving resistance testing results(up to 45 days)
  • Non-PI ARVs that were discontinued or initiated after receiving resistance testing results(up to 45 days)
  • Physician reported limitations that influence access to resistance testing(day 1)
  • Clinician reported reasons why tipranavir was or was not considered as an option for each patient(up to 45 days)

研究者

申办方类型
Industry

研究点 (1)

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