Clinical Trial Results:
A phase 3, open label, randomised, parallel group study to compare the effect on prevention and resolution of treatment related adverse events of a simplified, once daily regimen of a fixed dose combination tablet of emtricitabine and tenofovir DF versus twice daily co-formulated zidovudine and lamivudine (Combivir®) or zidovudine and lamivudine, in virologically suppressed, HIV infected patients taking efavirenz.
Summary
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EudraCT number |
2004-002254-59 |
Trial protocol |
IE GB |
Global completion date |
25 Jun 2007
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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 |
05 Jan 2017
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First version publication date |
05 Jan 2017
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Other versions |
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Summary report(s) |
GS-MC-164-0111_Summary |
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.