An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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