Stepped-Dose Versus Full-Dose Efavirenz for HIV Infection and Neuropsychiatric Adverse Events

Background: More than 50 % of patients who start efavirenz treat-ment develop limiting neuropsychiatric adverse events (NPAEs). Objective: To assess whether stepwise dosing of efavirenz de-creases the incidence and severity of NPAEs while maintaining virologic efficacy. Design: Randomized, double-blind, controlled trial. Setting: 7 HIV clinics in Spain. Patients: 114 HIV-infected patients eligible for efavirenz treatment plus 2 nucleoside or nucleotide reverse transcriptase inhibitors. Intervention: Random assignment (by computer-generated se-quence) to receive efavirenz, 200 mg/d on days 1 through 6, 400 mg/d on days 7 through 13, and 600 mg/d on day 14 and after, or efavirenz, 600 mg/d, from day 1. Both groups received 2 nu-cleoside or nucleotide reverse transcriptase inhibitors chosen by the patient’s physician