Clinical Trial Page

Clinical Trial Results:
An open-label trial of TMC125 in HIV-1 infected subjects who were randomized in any sponsor selected TMC125 trial to an active control arm and either virologically failed or completed the entire treatment period, or to placebo arm and were treated for at least 48 weeks.

Summary
EudraCT number
2004-001658-10
Trial protocol
GB   BE   IT   PT   ES  
Global completion date
20 Mar 2007

Paediatric regulatory details
Is the trial part of an agreed EMA paediatric investigation plan?
No
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006?
No
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006?
No

Results information
Results version number
v1(current)
This version publication date
06 Jul 2016
First version publication date
13 Jun 2015
Other versions
Summary report(s)
2004-001658-10_TMC125-C211 (CR006742)_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.
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