Clinical Trial Results:
Estudio fase IV, abierto, aleatorizado, controlado, para evaluar el efecto sobre el perfil lipídico del cambio de un régimen TARGA estable de dosis fija de abacavir/lamivudina (Kivexa) más lopinavir/ritonavir (Kaletra), a emtricitabina/tenofovir disoproxil fumarato (Truvada) más lopinavir/ritonavir (Kaletra) en sujetos adultos infectados con el VIH con colesterol elevado
A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching a Stable HAART Regimen of fixed dose Abacavir/Lamivudine (Kivexa) Plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) Plus Lopinavir/Ritonavir (Kaletra) in Adult HIV-1 Infected Subjects With Raised Cholesterol
Summary
|
|
EudraCT number |
2008-002043-16 |
Trial protocol |
ES DE AT IT |
Global completion date |
19 Oct 2009
|
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 |
05 Jan 2017
|
First version publication date |
05 Jan 2017
|
Other versions |
|
Summary report(s) |
GS-EU-164-0206_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.