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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.