Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage

Sociedad Andaluza de Enfermedades Infecciosas

Status and phase

Completed

Phase 4

Conditions

HIV-1 Infection

HIV Infection

Treatments

Drug: Efavirenz

Study type

Interventional

Funder types

NETWORK

Other

Identifiers

NCT00556634

SAEI_EFV

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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