Status:
COMPLETED
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00144287
Start Date
May 1 2004
End Date
April 1 2006
Last Update
November 5 2013
Active Locations (53)
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1
Boehringer Ingelheim Investigational Site
Aachen, Germany, 52062
2
Boehringer Ingelheim Investigational Site
Berlin, Germany, 10117
3
Boehringer Ingelheim Investigational Site
Berlin, Germany, 10243
4
Boehringer Ingelheim Investigational Site
Berlin, Germany, 10439