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

HIV Infection Clinical Trial

Official title:

Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556634
• Other study ID #: SAEI_EFV
• Status: Completed
• Phase: Phase 4
• First received: November 8, 2007
• Last updated: January 14, 2009
• Start date: April 2006
• Est. completion date: January 2008

Study information

• Verified date: January 2009
• Source: Sociedad Andaluza de Enfermedades Infecciosas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection
• HIV-1 Infection
• Infection

Intervention

Drug:
• Efavirenz
Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward) OR Efavirenz usual dosage (600 mg/day from the first day)

Locations

Country	Name	City	State
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 de Jerez	Jerez de la Frontera	Cadiz
Spain	Hospital Universitario Carlos Haya	Malaga
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitario de Valme	Seville
Spain	Hospital Universitario Virgen Macarena	Seville
Spain	Hospitales Universitarios Virgen del Rocio	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Andaluza de Enfermedades Infecciosas	Consejeria de Salud. Junta de Andalucia. Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of neuropsychiatric side effects		4 weeks	Yes
Secondary	Virological efficacy		24 weeks	No