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

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 Infections HIV Infections	Drug: Efavirenz	Phase IV

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Efavirenz

U.S. FDA Resources

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.

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 ]

Secondary Outcome Measures:

Virological efficacy [ Time Frame: 24 weeks ]

Enrollment:	100
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2007

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

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

Study ID Numbers:	SAEI_EFV
First Received:	November 8, 2007
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00556634
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:

HIV

efavirenz

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

Communicable Diseases

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Sociedad Andaluza de Enfermedades Infecciosas Consejeria de Salud. Junta de Andalucia. Spain
Information provided by:	Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:	NCT00556634