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

November 8, 2007
January 14, 2009
April 2006
January 2008   (final data collection date for primary outcome measure)
incidence and severity of neuropsychiatric side effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
incidence and severity of neuropsychiatric side effects [ Time Frame: 4 weeks ]
Complete list of historical versions of study NCT00556634 on ClinicalTrials.gov Archive Site
Virological efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Virological efficacy [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • HIV-1 Infection
  • HIV Infection
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)

  • Active Comparator: B
    Intervention: Drug: Efavirenz
  • Experimental: A
    Intervention: Drug: Efavirenz
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.
 
Completed
114
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00556634
SAEI_EFV
Yes
Luis Fernando Lopez-Cortes, Servicio Andaluz de Salud. Hospitales Uiversitarios Virgen del Rocíoi
Sociedad Andaluza de Enfermedades Infecciosas
Consejeria de Salud. Junta de Andalucia. Spain
Study Director: Luis F Lopez-Cortes, MD, PhD Hospitales Universitarios Virgen del Rocio. Seville. Spain
Sociedad Andaluza de Enfermedades Infecciosas
January 2009

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