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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Tipranavir/Ritonavir
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Epimed GmbH
  • Universitätskliniken Charité
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Klinikum der Ruhr-Universität Bochum
  • Medizinische Universitätsklinik Bonn
  • Klinikum Dortmund g GmbH
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Boehringer Ingelheim Investigational Site
  • Universitätsklinikum Düsseldorf
  • Boehringer Ingelheim Investigational Site
  • Universitätsklinik Erlangen-Nürnberg
  • Universitätsklinikum Essen
  • Klinikum der J.-W.-Goethe-Universität
  • Boehringer Ingelheim Investigational Site
  • Klinikum der Justus-Liebig-Universität
  • ifi Institut für Interdisziplinäre Infektiologie
  • IPM Study Center GmbH
  • Universitätsklinikum Hamburg-Eppendorf
  • Boehringer Ingelheim Investigational Site
  • Med. Hochschule Hannover
  • Universitätsklinik des Saarlandes
  • Universitätsklinikum im
  • Städtisches Krankenhaus Kemperhof
  • Krankenhaus der
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Universitätsklinik Köln
  • Städtisches Klinikum St. Georg
  • Johannes-Gutenberg-Universität Mainz
  • Boehringer Ingelheim Investigational Site
  • Medizinische Poliklinik
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Klinik und Poliklinik für Neurologie
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Klinium Natruper Holz
  • Klinikum Salzgitter GmbH
  • Boehringer Ingelheim Investigational Site
  • Medizinische Universitätsklinik Ulm
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash

Secondary Outcome Measures

The quantity of HIV-1 RNA
The CD4 cell count

Full Information

First Posted
September 2, 2005
Last Updated
November 4, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00144287
Brief Title
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tipranavir/Ritonavir
Primary Outcome Measure Information:
Title
The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters
Title
The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash
Secondary Outcome Measure Information:
Title
The quantity of HIV-1 RNA
Title
The CD4 cell count

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Aachen
ZIP/Postal Code
52062
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10243
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10627
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10719
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10777
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
10961
Country
Germany
Facility Name
Epimed GmbH
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Universitätskliniken Charité
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Klinikum der Ruhr-Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Medizinische Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum Dortmund g GmbH
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Duisburg
ZIP/Postal Code
47055
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Düsseldorf
ZIP/Postal Code
40237
Country
Germany
Facility Name
Universitätsklinik Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Klinikum der J.-W.-Goethe-Universität
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Freiburg
ZIP/Postal Code
79098
Country
Germany
Facility Name
Klinikum der Justus-Liebig-Universität
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
ifi Institut für Interdisziplinäre Infektiologie
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
IPM Study Center GmbH
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Med. Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinik des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum im
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Städtisches Krankenhaus Kemperhof
City
Koblenz
ZIP/Postal Code
56065
Country
Germany
Facility Name
Krankenhaus der
City
Köln
ZIP/Postal Code
50678
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Köln
ZIP/Postal Code
50679
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Köln
ZIP/Postal Code
50735
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Städtisches Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Johannes-Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Medizinische Poliklinik
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
ZIP/Postal Code
80801
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
ZIP/Postal Code
81669
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Münster
ZIP/Postal Code
48143
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Nürnberg
ZIP/Postal Code
90461
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Oldenburg
ZIP/Postal Code
28121
Country
Germany
Facility Name
Klinium Natruper Holz
City
Osnabrück
ZIP/Postal Code
49090
Country
Germany
Facility Name
Klinikum Salzgitter GmbH
City
Salzgitter
ZIP/Postal Code
38226
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Stuttgart
ZIP/Postal Code
70197
Country
Germany
Facility Name
Medizinische Universitätsklinik Ulm
City
Ulm
ZIP/Postal Code
89070
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Wuppertal
ZIP/Postal Code
42277
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.68_U06-2170.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.68_literature.pdf
Description
Related Info

Learn more about this trial

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

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