Observational Non-Interventional Study (Anwendungsbeobachtung) With Aptivus (Tipranavir) in HIV-Infected Patients
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Tipranavir (Drug)
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Pharma GmbH & Co. KG
Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage@rdg.boehringer-ingelheim.com
Summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durable suppress viral load and may achieve suppression of viral load below the limit of detection.
Clinical Details
Official title:
Observational Non-Interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-Dose Ritonavir in HIV Type 1 Infected Patients
Study design: Observational, Longitudinal, Defined Population, Prospective Study
Detailed description:
This observational study will assess efficacy and tolerability of treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir). Virologic efficacy will be assessed by evaluation of the HIV-RNA viral load. Immunological development will be assessed by CD4 cell count. Laboratory parameters (liver enzymes, lipids) will be evaluated for safety reasons. Side effects will be documented, and tolerability will be assessed by the investigator.
Study Hypothesis:
Treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) may durably suppress viral load and may achieve suppression of viral load below the limit of detection.
Comparison(s):
N. A.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
Age < 18 years 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.
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Email: clintriage@rdg.boehringer-ingelheim.com
Boehringer Ingelheim Investigational Site, Mainz, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Münster, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Freiburg, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Oldenburg, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Dortmund, Germany; Recruiting
Boehringer Ingelheim Investigational Site, München, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Aachen, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Halle/Saale, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Stuttgart, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Frankfurt/Main, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Hannover, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Homburg/Saar, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Hamburg, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Erlangen, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Magdeburg, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Saarbrücken, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Karlsruhe, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Leipzig, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Nürnberg, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Köln, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Krefeld, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Düsseldorf, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Osnabrück, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Berlin, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Gießen, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Wuppertal, Germany; Recruiting
Boehringer Ingelheim Investigational Site, Bremen, Germany; Recruiting
Additional Information
Ending date: April 2009
Last updated: October 2, 2007
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