Status:
APPROVED_FOR_MARKETING
An Open Label Safety Study of Tipranavir Co-administered With Low-dose Ritonavir in Patients With Advanced HIV-1 Infection and Limited Treatment Options.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00933205
Start Date
May 1 2004
Last Update
November 30 2016
Active Locations (215)
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1
1182.16.3202 Boehringer Ingelheim Investigational Site
Antwerp, Belgium
2
1182.16.3203 Boehringer Ingelheim Investigational Site
Brussels, Belgium
3
1182.16.3205 Boehringer Ingelheim Investigational Site
Brussels, Belgium
4
1182.16.3206 Boehringer Ingelheim Investigational Site
Brussels, Belgium