Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
- Conditions
- HIV Infections
- Registration Number
- NCT00144287
- Lead Sponsor
- Boehringer Ingelheim
- 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 who are triple antiretroviral class experienced with at least two previous PI-containing regimens.
The safety assessment will be performed by evaluating:
* The frequency of treatment-emergent adverse events (AEs) , all serious adverse events (SAEs), and additional safety laboratory parameters.
* The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.
The efficacy assessment will be performed by evaluating:
* The quantity of HIV-1 RNA
* The CD4 cell count.
Study Hypothesis:
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 who are triple antiretroviral class experienced with at least two previous PI-containing regimens.
Comparison(s):
N.A.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
- Secondary Outcome Measures
Name Time Method The quantity of HIV-1 RNA The CD4 cell count
Trial Locations
- Locations (28)
Epimed GmbH
🇩🇪Berlin, Germany
Städtisches Klinikum St. Georg
🇩🇪Leipzig, Germany
Johannes-Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Boehringer Ingelheim Investigational Site
🇩🇪Wuppertal, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Med. Hochschule Hannover
🇩🇪Hannover, Germany
Universitätskliniken Charité
🇩🇪Berlin, Germany
Klinikum der Ruhr-Universität Bochum
🇩🇪Bochum, Germany
Medizinische Universitätsklinik Bonn
🇩🇪Bonn, Germany
IPM Study Center GmbH
🇩🇪Hamburg, Germany
Klinikum Dortmund g GmbH
🇩🇪Dortmund, Germany
Städtisches Krankenhaus Kemperhof
🇩🇪Koblenz, Germany
Universitätsklinik Köln
🇩🇪Köln, Germany
Medizinische Poliklinik
🇩🇪München, Germany
Krankenhaus der
🇩🇪Köln, Germany
Klinikum Salzgitter GmbH
🇩🇪Salzgitter, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Klinikum der J.-W.-Goethe-Universität
🇩🇪Frankfurt/Main, Germany
Universitätsklinikum im
🇩🇪Kiel, Germany
Klinium Natruper Holz
🇩🇪Osnabrück, Germany
Medizinische Universitätsklinik Ulm
🇩🇪Ulm, Germany
ifi Institut für Interdisziplinäre Infektiologie
🇩🇪Hamburg, Germany
Klinikum der Justus-Liebig-Universität
🇩🇪Giessen, Germany
Universitätsklinik Erlangen-Nürnberg
🇩🇪Erlangen, Germany
Universitätsklinik des Saarlandes
🇩🇪Homburg/Saar, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinik und Poliklinik für Neurologie
🇩🇪Münster, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany