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Observational Non-Interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-Infected Patients.
This study is ongoing, but not recruiting participants.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00531206
  Purpose

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 durably suppress viral load and may achieve suppression of viral load below the limit of detection.


Condition
HIV Infections

MedlinePlus related topics: AIDS
Drug Information available for: Ritonavir Tipranavir
U.S. FDA Resources
Study Type: Observational
Official Title: Observational Non-Interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-Dose Ritonavir in HIV Type 1 Infected Patients

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • safety

Estimated Enrollment: 300
Study Start Date: August 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531206

Locations
Germany
Boehringer Ingelheim
Berlin, Germany
Boehringer Ingelheim
Düsseldorf, Germany
Boehringer Ingelheim
München, Germany
Boehringer Ingelheim
Frankfurt/Main, Germany
Boehringer Ingelheim
Stuttgart, Germany
Boehringer Ingelheim
Karlsruhe, Germany
Boehringer Ingelheim
Aachen, Germany
Boehringer Ingelheim
Hamburg, Germany
Boehringer Ingelheim
Saarbrücken, Germany
Boehringer Ingelheim
Oldenburg, Germany
Boehringer Ingelheim
Leipzig, Germany
Boehringer Ingelheim
Mainz, Germany
Boehringer Ingelheim
Hannover, Germany
Boehringer Ingelheim
Gießen, Germany
Boehringer Ingelheim
Köln, Germany
Boehringer Ingelheim
Münster, Germany
Boehringer Ingelheim
Osnabrück, Germany
Boehringer Ingelheim
Wuppertal, Germany
Boehringer Ingelheim
Bremen, Germany
Boehringer Ingelheim
Nürnberg, Germany
Boehringer Ingelheim
Magdeburg, Germany
Boehringer Ingelheim
Krefeld, Germany
Boehringer Ingelheim
Dortmund, Germany
Boehringer Ingelheim
Homburg/Saar, Germany
Boehringer Ingelheim
Halle/Saale, Germany
Boehringer Ingelheim
Freiburg, Germany
Boehringer Ingelheim
Erlangen, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1182.112
Study First Received: September 17, 2007
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00531206  
Health Authority: Germany:

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009