Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
NCT ID: NCT00531206
Last Updated: 2014-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
65 participants
OBSERVATIONAL
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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All participants
Tipranavir
Ritonavir
low dose
Interventions
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Tipranavir
Ritonavir
low dose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnant female patients
* Hypersensitivity to the active substance or to any of the excipients.
* Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
* Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
* Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
* Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Aachen, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Bremen, , Germany
Boehringer Ingelheim Investigational Site
Cologne, , Germany
Boehringer Ingelheim Investigational Site
Dortmund, , Germany
Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
Boehringer Ingelheim Investigational Site
Erlangen, , Germany
Boehringer Ingelheim Investigational Site
Frankfurt am Main, , Germany
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau, , Germany
Boehringer Ingelheim Investigational Site
Giessen, , Germany
Boehringer Ingelheim Investigational Site
Halle, , Germany
Boehringer Ingelheim Investigational Site
Hamburg, , Germany
Boehringer Ingelheim Investigational Site
Hanover, , Germany
Boehringer Ingelheim Investigational Site
Homburg/Saar, , Germany
Boehringer Ingelheim Investigational Site
Karlsruhe, , Germany
Boehringer Ingelheim Investigational Site
Krefeld, , Germany
Boehringer Ingelheim Investigational Site
Leipzig, , Germany
Boehringer Ingelheim Investigational Site
Magdeburg, , Germany
Boehringer Ingelheim Investigational Site
Mainz, , Germany
Boehringer Ingelheim Investigational Site
München, , Germany
Boehringer Ingelheim Investigational Site
Münster, , Germany
Boehringer Ingelheim Investigational Site
Nuremberg, , Germany
Boehringer Ingelheim Investigational Site
Oldenburg, , Germany
Boehringer Ingelheim Investigational Site
Osnabrück, , Germany
Boehringer Ingelheim Investigational Site
Saarbrücken, , Germany
Boehringer Ingelheim Investigational Site
Stuttgart, , Germany
Boehringer Ingelheim Investigational Site
Wuppertal, , Germany
Countries
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Other Identifiers
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1182.112
Identifier Type: -
Identifier Source: org_study_id
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