Clinical trial NCT00556634: Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1 Infection
HIV Infection
Keywords: HIV
efavirenz
central nervous system
adverse effects
Lead sponsor: Sociedad Andaluza de Enfermedades Infecciosas
Sponsor class: NETWORK
Collaborators: name: Junta de Andalucia
First posted: 2007-11-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: incidence and severity of neuropsychiatric side effects
timeFrame: 4 weeks
Secondary outcomes:
measure: Virological efficacy
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez
state: Cadiz
city: Almeria
country: Spain
facility: Hospital Torrecardenas
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
city: Malaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Seville
country: Spain
facility: Hospitales Universitarios Virgen del Rocio
city: Seville
country: Spain
facility: Hospital Universitario de Valme
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocio. Seville. Spain
name: Luis F Lopez-Cortes, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Gutierrez-Valencia A, Viciana P, Palacios R, Ruiz-Valderas R, Lozano F, Terron A, Rivero A, Lopez-Cortes 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. doi: 10.7326/0003-4819-151-3-200908040-00127. Epub 2009 Jul 6.