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abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim’s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical study report - had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non-approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country. Additional information on this study and the drug concerned may be provided upon request based on Boehringer Ingelheim’s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of Boehringer Ingelheim. Additional data are available under http://clinicaltrials.gov/. V1.0/2014 Boehringer Ingelheim BI Trial No.: 1182.112 1. - 15. CTR Main Part Page 3 U10-1047-01 Name of company: Boehringer Ingelheim Tabulated Trial Report ABCD Name of finished product: Aptivus® Name of active ingredient: Page: Tipranavir 1 of 3 Module: Volume: Report date: 28 JAN 2010 Trial No. / U No.: 1182.112 / U101047-01 Date of trial: 20 SEP 2006 – 29 JAN 2009 Synopsis No.: Date of revision (if applicable): Proprietary confidential information © 2010 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Title of trial: Non-interventional observational study of antiretroviral combination therapy with Aptivus® (tipranavir) and low-dose Norvir® (ritonavir) in HIV-infected patients Principal/Coordinating Investigator: Not applicable Trial sites: 49 specialist centres in Germany experienced in treating HIV infected patients. Publication (reference): Not published Clinical phase: Not applicable Objectives: HIV-infected patients in advanced stage of disease, developing resistance or treatment failure after multiple pre-treatment with antiretroviral drugs, including protease inhibitors, need an antiretroviral regimen including a new generation protease inhibitor to establish a successful treatment option. Aptivus® (tipranavir) in combination with low-dose Norvir® (ritonavir) is an antiretroviral treatment option that has been shown to be superior to control protease inhibitors in phase III clinical trials in treatment experienced patients with multi-drug resistant HIV-1 infection. The purpose of this non-interventional observational study was to observe safety and tolerability of antiretrovial regimens including Aptivus® (tipranavir) and low-dose Norvir® (ritonavir) in widespread medical routine practice. The main parameters to be observed for efficacy were virus load and CD4 cell count. Methodology: Non-interventional observational study No. of subjects: planned: entered: 300 actual: enrolled: 65 Treatment with Aptivus® (tipranavir) and low-dose Norvir® (ritonavir): entered: 65 treated: 65 analysed Boehringer Ingelheim BI Trial No.: 1182.112 1. - 15. CTR Main Part Page 4 U10-1047-01 Name of company: Boehringer Ingelheim Tabulated Trial Report ABCD Name of finished product: Aptivus® Name of active ingredient: Page: Tipranavir 2 of 3 Module: Volume: Report date: 28 JAN 2010 Trial No. / U No.: 1182.112 / U101047-01 Date of trial: 20 SEP 2006 – 29 JAN 2009 Synopsis No.: Date of revision (if applicable): Proprietary confidential information © 2010 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. Diagnosis and main criteria for inclusion: 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. Test product: Aptivus® (tipranavir) in combination with low-dose Norvir® (ritonavir) dose: 500mg Aptivus® (tipranavir) with 200mg Norvir® (ritonavir) twice daily mode of admin.: Per oral batch no.: Commercial product Reference therapy: Not applicable dose: Not applicable mode of admin.: Not applicable batch no.: Not applicable Duration of treatment: 52 weeks Criteria for evaluation: Efficacy / clinical pharmacology: CD4 cell count; viral load Safety: Adverse events and serious adverse events were collected, documented and reported Statistical methods: Descriptive statistical analysis Boehringer Ingelheim BI Trial No.: 1182.112 1. - 15. CTR Main Part Page 5 U10-1047-01 Name of company: Boehringer Ingelheim Tabulated Trial Report ABCD Name of finished product: Aptivus® Name of active ingredient: Page: Tipranavir 3 of 3 Module: Volume: Report date: 28 JAN 2010 Trial No. / U No.: 1182.112 / U101047-01 Date of trial: 20 SEP 2006 – 29 JAN 2009 Synopsis No.: Date of revision (if applicable): Proprietary confidential information © 2010 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission. SUMMARY – CONCLUSIONS: Overall, these highly treatment experienced patients who were treated with Efficacy / clinical ® ® pharmacology results: Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) had a reduction in their HIV viral load and an increase in their CD4+ cell count. The median change in viral load reported after 4 weeks in 47 evaluable patients was -1.56 log10 HIV-RNA copies /mL (Inter Quartile Range (IQR): -0.54, 1.94) showing a rapid therapeutical response. At visit month 12 analysis of 41 evaluable patients showed a median change of viral load of -1.45 log10 HIV-RNA copies/mL (IQR: -0.54, -2.42). At visit month 12 analysis of 41 evaluable patients showed a median increase in CD4+ cell count of 36 cells/mm3 (IQR: -5, 191). The results seen in these patients show that Aptivus® (tipranavir) in combination with low-dose Norvir® (ritonavir) is an active agent in the treatment of HIV infected, treatment-experienced patients. 23 patients (35.4%) reported any adverse events during the non-interventional Safety results: study. 6 patients (9.2%) discontinued due to a non-serious adverse event and 2 patients (3%) discontinued due to a serious adverse event. 5 patients (7.7%) discontinued due to TPV/r related adverse events. The overall percentage of patients experiencing a treatment emergent adverse event was lower than the observed numbers in the phase III clinical studies with tipranavir. Conclusions: In summary this German non-interventional observational, multicenter study observed 65 HIV-1 infected patients who were treated with an antiretroviral regimen including Aptivus® (tipranavir) in combination with low-dose Norvir® (ritonavir). The median change in HIV RNA viral load and CD4 cell count from baseline were consistent with that observed in phase III studies. In summary, there were no unexpected safety findings in this non-interventional observational study.