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

Primary Purpose

HIV-1 Infection, HIV Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Efavirenz
Sponsored by
Sociedad Andaluza de Enfermedades Infecciosas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection focused on measuring HIV, efavirenz, central nervous system, adverse effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Jerez
  • Hospital Torrecardenas
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario Reina Sofía
  • Hospital Juan Ramon Jimenez
  • Hospital Universitario Carlos Haya
  • Hospital Universitario Virgen de la Victoria
  • Hospitales Universitarios Virgen del Rocio
  • Hospital Universitario de Valme
  • Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

B

A

Arm Description

Outcomes

Primary Outcome Measures

incidence and severity of neuropsychiatric side effects

Secondary Outcome Measures

Virological efficacy

Full Information

First Posted
November 8, 2007
Last Updated
January 14, 2009
Sponsor
Sociedad Andaluza de Enfermedades Infecciosas
Collaborators
Consejeria de Salud. Junta de Andalucia. Spain
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1. Study Identification

Unique Protocol Identification Number
NCT00556634
Brief Title
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

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sociedad Andaluza de Enfermedades Infecciosas
Collaborators
Consejeria de Salud. Junta de Andalucia. Spain

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection, HIV Infection
Keywords
HIV, efavirenz, central nervous system, adverse effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Description
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)
Primary Outcome Measure Information:
Title
incidence and severity of neuropsychiatric side effects
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Virological efficacy
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis F Lopez-Cortes, MD, PhD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocio. Seville. Spain
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Jerez
City
Jerez de la Frontera
State/Province
Cadiz
Country
Spain
Facility Name
Hospital Torrecardenas
City
Almeria
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
Country
Spain
Facility Name
Hospital Juan Ramon Jimenez
City
Huelva
Country
Spain
Facility Name
Hospital Universitario Carlos Haya
City
Malaga
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospitales Universitarios Virgen del Rocio
City
Seville
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario de Valme
City
Seville
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Seville
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19581631
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.
Results Reference
derived

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

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