Trial record 2 of 15 for:    " November 07, 2007":" December 07, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Consejeria de Salud. Junta de Andalucia. Spain
Information provided by:
Sociedad Andaluza de Enfermedades Infecciosas
ClinicalTrials.gov Identifier:
NCT00556634
First received: November 8, 2007
Last updated: January 14, 2009
Last verified: January 2009
  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 Infection
HIV Infection
Drug: Efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Virological efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: April 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B 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)

Experimental: A 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556634

Locations
Spain
Hospital de Jerez
Jerez de la Frontera, Cadiz, 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 Carlos Haya
Malaga, Spain
Hospital Universitario Virgen de la Victoria
Malaga, Spain
Hospital Universitario de Valme
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospitales Universitarios Virgen del Rocio
Seville, Spain, 41013
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

No publications provided by Sociedad Andaluza de Enfermedades Infecciosas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Fernando Lopez-Cortes, Servicio Andaluz de Salud. Hospitales Uiversitarios Virgen del Rocíoi
ClinicalTrials.gov Identifier: NCT00556634     History of Changes
Other Study ID Numbers: SAEI_EFV
Study First Received: November 8, 2007
Last Updated: January 14, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Sociedad Andaluza de Enfermedades Infecciosas:
HIV
efavirenz
central nervous system
adverse effects

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Efavirenz
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014