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HIV InfectionsPhase 3NCT00144287

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

A Phase 3 study testing Tipranavir/Ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 53 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Tipranavir/Ritonavir
How many people
255 participants
Where
53 sitesGermany
Study dates
May 2004to Apr 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Germany53 sites

  • Boehringer Ingelheim Investigational Site

    Aachen, 52062

  • Boehringer Ingelheim Investigational Site

    Berlin, 10117

  • Boehringer Ingelheim Investigational Site

    Berlin, 10243

  • Boehringer Ingelheim Investigational Site

    Berlin, 10439

  • Boehringer Ingelheim Investigational Site

    Berlin, 10627

  • Boehringer Ingelheim Investigational Site

    Berlin, 10707

  • Boehringer Ingelheim Investigational Site

    Berlin, 10719

  • Boehringer Ingelheim Investigational Site

    Berlin, 10777

  • Boehringer Ingelheim Investigational Site

    Berlin, 10961

  • Epimed GmbH

    Berlin, 12157

  • Universitätskliniken Charité

    Berlin, 12203

  • Boehringer Ingelheim Investigational Site

    Berlin, 13347

  • Boehringer Ingelheim Investigational Site

    Berlin, 14057

  • Klinikum der Ruhr-Universität Bochum

    Bochum, 44791

  • Medizinische Universitätsklinik Bonn

    Bonn, 53105

  • Krankenhaus der

    Cologne, 50678

  • Boehringer Ingelheim Investigational Site

    Cologne, 50679

  • Boehringer Ingelheim Investigational Site

    Cologne, 50735

  • Universitätsklinik Köln

    Cologne, 50924

  • Klinikum Dortmund g GmbH

    Dortmund, 44137

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Boehringer Ingelheim Investigational Site

    Duisburg, 47055

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Boehringer Ingelheim Investigational Site

    Düsseldorf, 40237

  • Universitätsklinik Erlangen-Nürnberg

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinikum der J.-W.-Goethe-Universität

    Frankfurt am Main, 60590

  • Boehringer Ingelheim Investigational Site

    Freiburg im Breisgau, 79098

  • Klinikum der Justus-Liebig-Universität

    Giessen, 35392

  • ifi Institut für Interdisziplinäre Infektiologie

    Hamburg, 20099

  • IPM Study Center GmbH

    Hamburg, 20146

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Boehringer Ingelheim Investigational Site

    Hanover, 30159

  • Med. Hochschule Hannover

    Hanover, 30625

  • Universitätsklinik des Saarlandes

    Homburg/Saar, 66421

  • Universitätsklinikum im

    Kiel, 24116

  • Städtisches Krankenhaus Kemperhof

    Koblenz, 56065

  • Städtisches Klinikum St. Georg

    Leipzig, 04129

  • Johannes-Gutenberg-Universität Mainz

    Mainz, 55131

  • Boehringer Ingelheim Investigational Site

    München, 80335

  • Medizinische Poliklinik

    München, 80336

  • Boehringer Ingelheim Investigational Site

    München, 80801

  • Boehringer Ingelheim Investigational Site

    München, 81669

  • Boehringer Ingelheim Investigational Site

    Münster, 48143

  • Boehringer Ingelheim Investigational Site

    Münster, 48149

  • Klinik und Poliklinik für Neurologie

    Münster, 48149

  • Boehringer Ingelheim Investigational Site

    Nuremberg, 90461

  • Boehringer Ingelheim Investigational Site

    Oldenburg, 28121

  • Klinium Natruper Holz

    Osnabrück, 49090

  • Klinikum Salzgitter GmbH

    Salzgitter, 38226

  • Boehringer Ingelheim Investigational Site

    Stuttgart, 70197

  • Medizinische Universitätsklinik Ulm

    Ulm, 89070

  • Boehringer Ingelheim Investigational Site

    Wuppertal, 42277

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
Tipranavir/Ritonavir
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tipranavir/RitonavirDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters

  2. The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash

Secondary outcomes (2)

  1. The quantity of HIV-1 RNA

  2. The CD4 cell count

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionApr 2006
  4. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00144287
Sponsor's protocol ID
1182.68
Status last verified
Nov 2013
First submitted
2 Sep 2005
Last updated
5 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tipranavir/Ritonavir in people with HIV Infections, run by Boehringer Ingelheim at 53 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The frequency of treatment-emergent adverse events (AEs), all serious AEs, and additional safety laboratory parameters. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00144287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.

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