NCT00556634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 15, 2009

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

November 8, 2007

Last Update Submit

January 14, 2009

Conditions

HIV-1 InfectionHIV Infection

Keywords

HIVefavirenzcentral nervous systemadverse effects

Outcome Measures

Primary Outcomes (1)

  • incidence and severity of neuropsychiatric side effects

    4 weeks

Secondary Outcomes (1)

  • Virological efficacy

    24 weeks

Study Arms (2)

B

ACTIVE COMPARATOR
Drug: Efavirenz

A

EXPERIMENTAL
Drug: Efavirenz

Interventions

EfavirenzDRUG

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)

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Torrecardenas

Almería, Almeria, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Cadiz, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Cordoba, Spain

Location

Hospital Juan Ramon Jimenez

Huelva, Huelva, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Malaga, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain

Location

Hospitales Universitarios Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Hospital Universitario de Valme

Seville, Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Seville, Spain

Location

Related Publications (1)

  • 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.

    PMID: 19581631DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Luis F Lopez-Cortes, MD, PhD

    Hospitales Universitarios Virgen del Rocio. Seville. Spain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 12, 2007

Study Start

April 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

January 15, 2009

Record last verified: 2009-01

Locations

ES(10)