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Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

NCT00792584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-09-12

No results posted yet for this study

Summary

Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation.

The investigators plan a twelve week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus etravirine, in group 2, efavirenz would be continued, and etravirine placebo given in addition. After six weeks, patients in group 1 would switch to the regimen of group 2, and vice versa.

The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.

Conditions

  • Sleep Disorders

Interventions

DRUG

etravirine

Patient receives etravirine/ placebo or efavirenz / placebo

DRUG

efavirenz

patient receives efavirenz / placebo or etravirine / placebo

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

  • University of Lausanne Hospitals

    collaborator OTHER

  • Hospital Lugano

    collaborator UNKNOWN

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Hospital of Neuchâtel

    collaborator UNKNOWN

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Bernard BH Hirschel, Professor · Geneva Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-11-30
Completion
2009-06-30

Countries

  • Switzerland

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 NCT00792584 on ClinicalTrials.gov