Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of
subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV
given as a stepped dosage over 2 weeks versus the usual dosage.
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage
(arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was
compared with conventional administration (arm B: 600 mg qd from the first day). All patients
received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type
scale specifically designed. Efficacy was assessed by percent of virological failures.