Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

HIV Infections Clinical Trial

Official title:

An Open Label Safety Study of Tipranavir Co-Administered With Low-Dose Ritonavir (TVP/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144287
• Other study ID #: 1182.68
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: November 4, 2013
• Start date: May 2004
• Est. completion date: April 2006

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Age >= 18 years

3. Patient is willing to use an effective barrier method of contraception for the duration of study participation and up to three months thereafter

4. Patient voluntarily provides written informed consent to participate, in compliance with local law

Exclusion Criteria:

1. Hypersensitivity to active ingredients or any of the excipients in tipranavir or ritonavir

2. Required use of restricted medications

3. Female patients of childbearing potential who:

• Have a positive pregnancy test at baseline or

• Are breast feeding.

4. 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.

5. Use of other investigational drugs, within 30 days prior to TPV/r initiation and for the duration of study participation.

6. 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection

Intervention

Drug:
• Tipranavir/Ritonavir

Locations

Country	Name	City	State
Germany	Boehringer Ingelheim Investigational Site	Aachen
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Epimed GmbH	Berlin
Germany	Universitätskliniken Charité	Berlin
Germany	Klinikum der Ruhr-Universität Bochum	Bochum
Germany	Medizinische Universitätsklinik Bonn	Bonn
Germany	Klinikum Dortmund g GmbH	Dortmund
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	Boehringer Ingelheim Investigational Site	Duisburg
Germany	Boehringer Ingelheim Investigational Site	Düsseldorf
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinik Erlangen-Nürnberg	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Klinikum der J.-W.-Goethe-Universität	Frankfurt/Main
Germany	Boehringer Ingelheim Investigational Site	Freiburg
Germany	Klinikum der Justus-Liebig-Universität	Giessen
Germany	ifi Institut für Interdisziplinäre Infektiologie	Hamburg
Germany	IPM Study Center GmbH	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Boehringer Ingelheim Investigational Site	Hannover
Germany	Med. Hochschule Hannover	Hannover
Germany	Universitätsklinik des Saarlandes	Homburg/Saar
Germany	Universitätsklinikum im	Kiel
Germany	Städtisches Krankenhaus Kemperhof	Koblenz
Germany	Boehringer Ingelheim Investigational Site	Köln
Germany	Boehringer Ingelheim Investigational Site	Köln
Germany	Krankenhaus der	Köln
Germany	Universitätsklinik Köln	Köln
Germany	Städtisches Klinikum St. Georg	Leipzig
Germany	Johannes-Gutenberg-Universität Mainz	Mainz
Germany	Boehringer Ingelheim Investigational Site	München
Germany	Boehringer Ingelheim Investigational Site	München
Germany	Boehringer Ingelheim Investigational Site	München
Germany	Medizinische Poliklinik	München
Germany	Boehringer Ingelheim Investigational Site	Münster
Germany	Boehringer Ingelheim Investigational Site	Münster
Germany	Klinik und Poliklinik für Neurologie	Münster
Germany	Boehringer Ingelheim Investigational Site	Nürnberg
Germany	Boehringer Ingelheim Investigational Site	Oldenburg
Germany	Klinium Natruper Holz	Osnabrück
Germany	Klinikum Salzgitter GmbH	Salzgitter
Germany	Boehringer Ingelheim Investigational Site	Stuttgart
Germany	Medizinische Universitätsklinik Ulm	Ulm
Germany	Boehringer Ingelheim Investigational Site	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
Primary	The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash
Secondary	The quantity of HIV-1 RNA
Secondary	The CD4 cell count

External Links

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