Description:

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

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Versions (1)
  1. 12/11/13 12/11/13 - Martin Dugas
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December 11, 2013

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00144287 # HIV-1 Infection

German English
Details

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
No Healthy Volunteers
Triple antiretroviral class experienced patients with at least two previous PI-based regimens, who had failed or are intolerant to currently approved HIV-1 treatments
Age >= 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
Exclusion criteria
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(s) which, in the opinion of the investigator, would interfere with the patient´s ability to participate in or adhere to the requirements of this protocol.
Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.
Hepatic impairment(*) evidenced by the following baseline laboratory findings: - AST or ALT >5X upper limit of normal (ULN) or total bilirubin >3.5X ULN or - AST or ALT >2.5X ULN and total bilirubin >2X ULN (*) Patients with liver enzymes outside this range will be restricted from participation in this safety study until more data become available from ongoing phase III clinical studies.
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