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

This study has been completed.

Sponsor:

Collaborator:

Consejeria de Salud. Junta de Andalucia. Spain

Information provided by:

Sociedad Andaluza de Enfermedades Infecciosas

ClinicalTrials.gov Identifier:

NCT00556634

First received: November 8, 2007

Last updated: January 14, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2007

Last Updated Date

January 14, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

incidence and severity of neuropsychiatric side effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

incidence and severity of neuropsychiatric side effects [ Time Frame: 4 weeks ]

Change History

Complete list of historical versions of study NCT00556634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Virological efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Virological efficacy [ Time Frame: 24 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

HIV-1 Infection
HIV Infection

Intervention ^ICMJE

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)

Efavirenz usual dosage (600 mg/day from the first day)

Study Arm (s)

Active Comparator: B
Intervention: Drug: Efavirenz
Experimental: A
Intervention: Drug: Efavirenz

Publications *

Gutiérrez-Valencia A, Viciana P, Palacios R, Ruiz-Valderas R, Lozano F, Terrón A, Rivero A, López-Cortés LF; Sociedad Andaluza de Enfermedades Infecciosas. Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. Ann Intern Med. 2009 Aug 4;151(3):149-56. Epub 2009 Jul 6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

114

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00556634

Other Study ID Numbers ^ICMJE

SAEI_EFV

Has Data Monitoring Committee

Yes

Responsible Party

Luis Fernando Lopez-Cortes, Servicio Andaluz de Salud. Hospitales Uiversitarios Virgen del Rocíoi

Study Sponsor ^ICMJE

Sociedad Andaluza de Enfermedades Infecciosas

Collaborators ^ICMJE

Consejeria de Salud. Junta de Andalucia. Spain

Investigators ^ICMJE

Study Director:

Luis F Lopez-Cortes, MD, PhD

Hospitales Universitarios Virgen del Rocio. Seville. Spain

Information Provided By

Sociedad Andaluza de Enfermedades Infecciosas

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top