Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00531206
First received: September 17, 2007
Last updated: May 18, 2012
Last verified: May 2012
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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 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Tipranavir
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Adverse Events [ Time Frame: 52 weeks ]The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
Secondary Outcome Measures:
- Change in Viral Load [ Time Frame: Baseline and 52 weeks ]Log10 change from baseline in viral load over time
- CD4+ Cell Count [ Time Frame: Baseline and 52 weeks ]Change from baseline in CD4+ count over time
- Subjective Well-being [ Time Frame: 52 weeks ]Investigator's opinion of patient's general condition (quality of life)
| Enrollment: | 65 |
| Study Start Date: | August 2006 |
| Primary Completion Date: | January 2009 (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 |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients
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 Investigational Site | |
| Aachen, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Bremen, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Dortmund, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Düsseldorf, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Erlangen, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Frankfurt/Main, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Freiburg, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Gießen, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Halle/Saale, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Hannover, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Homburg/Saar, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Karlsruhe, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Krefeld, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Köln, 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 | |
| Nürnberg, 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 | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00531206 History of Changes |
| Other Study ID Numbers: | 1182.112 |
| Study First Received: | September 17, 2007 |
| Results First Received: | January 28, 2010 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Germany: |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013