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Completed

NCT Number: NCT00556634

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

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.

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Key information

Conditions

HIV-1 Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Torrecardenas, Almería, Almeria, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efavirenz

Drug

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 outcomes

  1. incidence and severity of neuropsychiatric side effects

    Time frame: 4 weeks

Secondary outcomes

  1. Virological efficacy

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sociedad Andaluza de Enfermedades Infecciosas

Network

Collaborators

  • Junta de Andalucia

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 12, 2007
Registry last updated
Jan 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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