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...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-008655-42

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

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Extrait

To compare the proportion of subjects with at least one treatment-emergent Grade 1-4 CNS or psychiatric adverse event, observed between Baseline through Week 12 and judged by the investigator to be at least possibly related to the study drug, in the ETR group versus the control group (EFV), respectively.


Critère d'inclusion

  • HIV-1 infection