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

Sponsor:	Sociedad Andaluza de Enfermedades Infecciosas
Collaborator:	Consejeria de Salud. Junta de Andalucia. Spain
Information provided by:	Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:	NCT00556634

Purpose

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.

Condition	Intervention	Phase
HIV-1 Infection HIV Infection	Drug: Efavirenz	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz

U.S. FDA Resources

Further study details as provided by Sociedad Andaluza de Enfermedades Infecciosas:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	114
Study Start Date:	April 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator	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)
A: Experimental	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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556634

Locations

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 Virgen de la Victoria
Malaga, Spain
Hospital Universitario Carlos Haya
Malaga, Spain
Hospital Universitario de Valme
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospitales Universitarios Virgen del Rocio
Seville, Spain, 41013
Spain, Cadiz
Hospital de Jerez
Jerez de la Frontera, Cadiz, Spain

Sponsors and Collaborators

Sociedad Andaluza de Enfermedades Infecciosas

Consejeria de Salud. Junta de Andalucia. Spain

Investigators

Study Director:

Luis F Lopez-Cortes, MD, PhD

Hospitales Universitarios Virgen del Rocio. Seville. Spain

More Information

No publications provided by Sociedad Andaluza de Enfermedades Infecciosas

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Servicio Andaluz de Salud. Hospitales Uiversitarios Virgen del Rocíoi ( Luis Fernando Lopez-Cortes )
Study ID Numbers:	SAEI_EFV
Study First Received:	November 8, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00556634 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:

HIV
efavirenz
central nervous system
adverse effects

Additional relevant MeSH terms:

Anti-Infective Agents
Efavirenz
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010