Clinical Trial Results:
A Phase II, randomized, active controlled, open label trial to investigate the efficacy and tolerability of TMC125 in HIV-1 infected subjects, who are PI-naïve and with documented genotypic evidence of NNRTI resistance from previous NNRTI use.
A sub-study of TMC125-C227 to evaluate the pharmacokinetic profile at baseline and at week 4 of TMC125 administered in addition to 2 investigators-selected NRTIs (vers. 3.0, 26 sept 2005)
Summary
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EudraCT number |
2004-001657-29 |
Trial protocol |
GB ES |
Global completion date |
11 Jul 2006
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jul 2016
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First version publication date |
18 Jun 2015
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Other versions |
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Summary report(s) |
2004-001657-29_TMC125-C227 (CR006730)_CSR Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.