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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sociedad Andaluza de Enfermedades Infecciosas
• Collaborator: Consejeria de Salud. Junta de Andalucia. Spain
• Treatments: Efavirenz

Criteria

Inclusion Criteria:

• Age older than 18 years

• HIV-1 infection

• Women of child-bearing age: negative pregnancy test

• Ability to understand and sign a written consent form

Exclusion Criteria:

• Pregnancy..

• Illegal drug or methadone use.

• Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks

• Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.

• Hepatic insufficiency