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

NCT00556634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2009-01-15

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection
  • HIV Infection

Interventions

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)

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV

  • Sociedad Andaluza de Enfermedades Infecciosas

    lead NETWORK

Principal Investigators

  • Luis F Lopez-Cortes, MD, PhD · Hospitales Universitarios Virgen del Rocio. Seville. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556634 on ClinicalTrials.gov