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

November 4, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52062
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 14057
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 12157
        • EPIMED GmbH
      • Berlin, Germany, 10117
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10243
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10439
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10627
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10707
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10719
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10777
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 10961
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany, 12203
        • Universitätskliniken Charité
      • Berlin, Germany, 13347
        • Boehringer Ingelheim Investigational Site
      • Bochum, Germany, 44791
        • Klinikum der Ruhr-Universität Bochum
      • Bonn, Germany, 53105
        • Medizinische Universitätsklinik Bonn
      • Dortmund, Germany, 44137
        • Klinikum Dortmund g GmbH
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus Dresden
      • Duisburg, Germany, 47055
        • Boehringer Ingelheim Investigational Site
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Düsseldorf, Germany, 40237
        • Boehringer Ingelheim Investigational Site
      • Erlangen, Germany, 91054
        • Universitätsklinik Erlangen-Nürnberg
      • Essen, Germany, 45122
        • Universitatsklinikum Essen
      • Frankfurt/Main, Germany, 60590
        • Klinikum der J.-W.-Goethe-Universität
      • Freiburg, Germany, 79098
        • Boehringer Ingelheim Investigational Site
      • Giessen, Germany, 35392
        • Klinikum der Justus-Liebig-Universität
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 20099
        • ifi Institut für interdisziplinäre Infektiologie
      • Hamburg, Germany, 20146
        • IPM Study Center GmbH
      • Hannover, Germany, 30625
        • Med. Hochschule Hannover
      • Hannover, Germany, 30159
        • Boehringer Ingelheim Investigational Site
      • Homburg/Saar, Germany, 66421
        • Universitätsklinik des Saarlandes
      • Kiel, Germany, 24116
        • Universitätsklinikum im
      • Koblenz, Germany, 56065
        • Städtisches Krankenhaus Kemperhof
      • Köln, Germany, 50924
        • Universitätsklinik Köln
      • Köln, Germany, 50678
        • Krankenhaus der
      • Köln, Germany, 50679
        • Boehringer Ingelheim Investigational Site
      • Köln, Germany, 50735
        • Boehringer Ingelheim Investigational Site
      • Leipzig, Germany, 04129
        • Städtisches Klinikum St. Georg
      • Mainz, Germany, 55131
        • Johannes-Gutenberg-Universität Mainz
      • München, Germany, 80335
        • Boehringer Ingelheim Investigational Site
      • München, Germany, 80336
        • Medizinische Poliklinik
      • München, Germany, 80801
        • Boehringer Ingelheim Investigational Site
      • München, Germany, 81669
        • Boehringer Ingelheim Investigational Site
      • Münster, Germany, 48143
        • Boehringer Ingelheim Investigational Site
      • Münster, Germany, 48149
        • Boehringer Ingelheim Investigational Site
      • Münster, Germany, 48149
        • Klinik und Poliklinik fur Neurologie
      • Nürnberg, Germany, 90461
        • Boehringer Ingelheim Investigational Site
      • Oldenburg, Germany, 28121
        • Boehringer Ingelheim Investigational Site
      • Osnabrück, Germany, 49090
        • Klinium Natruper Holz
      • Salzgitter, Germany, 38226
        • Klinikum Salzgitter GmbH
      • Stuttgart, Germany, 70197
        • Boehringer Ingelheim Investigational Site
      • Ulm, Germany, 89070
        • Medizinische Universitätsklinik Ulm
      • Wuppertal, Germany, 42277
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
The quantity of HIV-1 RNA
The CD4 cell count

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

April 1, 2006

Study Completion

April 1, 2006

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182.68

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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