Clinical Trial Results:
A Phase IIb, multi-centre, randomised, double-blind, active-controlled, trial comparing the neuropsychiatric adverse event profile of etravirine 400 mg q.d. versus efavirenz 600 mg q.d. in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral therapy-naïve HIV-1 infected subjects.
Summary
|
|
EudraCT number |
2008-008655-42 |
Trial protocol |
DK HU AT DE GB FR ES IT |
Global completion date |
12 Jan 2011
|
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 |
19 Aug 2016
|
First version publication date |
19 Aug 2016
|
Other versions |
|
Summary report(s) |
TMC125VIR2038 (2008-008655-42)_Ct.gov_Results |
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.