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

Phase 4

Completed

• Conditions: HIV-1 Infection; HIV Infection
• Interventions: Drug: Efavirenz

• Registration Number: NCT00556634
• Lead Sponsor: Sociedad Andaluza de Enfermedades Infecciosas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-14
• Last Update Posted: 2009-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Efavirenz	-
A	Efavirenz	-

Primary Outcome Measures

Name	Time	Method
incidence and severity of neuropsychiatric side effects	4 weeks

Secondary Outcome Measures

Name	Time	Method
Virological efficacy	24 weeks

Trial Locations

Locations (10)

Hospital de Jerez; 🇪🇸 Jerez de la Frontera, Cadiz, Spain

Hospital Torrecardenas; 🇪🇸 Almeria, Spain

Hospital Universitario Puerta del Mar; 🇪🇸 Cadiz, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Cordoba, Spain

Hospital Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario Carlos Haya; 🇪🇸 Malaga, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospitales Universitarios Virgen del Rocio; 🇪🇸 Seville, Spain

Hospital Universitario de Valme; 🇪🇸 Seville, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Seville, Spain