An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options.

Boehringer Ingelheim215 个研究点分布在 4 个国家开始时间: 2004年5月最近更新: 2016年11月30日

适应症

试验速览

阶段: 不适用
状态: Approved For Marketing
发起方: Boehringer Ingelheim
试验地点: 215

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this Open Label Safety Study is to provide access to and evaluate the safety and tolerability of TPV/r in treatment-experienced patients with advanced HIV-1 infection who have failed at least two PI-containing regimens, and have limited treatment options.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Triple anti-retroviral class experienced patients with at least 2 previous PI-based regimens who had failed or are intolerant to currently approved HIV-1 treatments.
•Age equal or more than 18 years
•Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter
•Patient voluntarily provides written informed consent to participate, in compliance with local law.

排除标准

•Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir
•Required use of restricted medications.
•Female patients of childbearing potential who have a positive pregnancy test at baseline or are breast feeding.
•Any medical condition which in the opinion of the investigator would interfere with the patients' ability to participate in or adhere to the requirements of this protocol.
•Use of other investigational drugs, within 30 days prior to TPV boosted with ritonavir initiation and for the duration of study participation
•Hepatic impairment evidenced by the following baseline laboratory findings:
•AST or ALT more than 5X ULN or total bilirubin more than 3.5X ULN
•AST or ALT more 2.5X ULN and total bilirubin more 2X ULN

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

研究点 (215)

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