Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz (SWITCH-EE)

This study has been completed.
Sponsor:
Collaborators:
University of Bern
University of Lausanne Hospitals
Hospital Lugano
University Hospital, Basel, Switzerland
Hospital of Neuchâtel
Information provided by (Responsible Party):
Alain Nguyen, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00792584
First received: November 17, 2008
Last updated: September 9, 2011
Last verified: September 2011

November 17, 2008
September 9, 2011
November 2008
November 2008   (final data collection date for primary outcome measure)
Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00792584 on ClinicalTrials.gov Archive Site
  • Levels of daytime sleepiness [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
  • Sleep Quality [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
  • Patient preference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Symptoms of depression, anxiety and stress will be assessed [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sleep Disorders
  • Drug: etravirine
    Patient receives etravirine/ placebo or efavirenz / placebo
  • Drug: efavirenz
    patient receives efavirenz / placebo or etravirine / placebo
  • Experimental: 1
    patients treats with etravirine for 6 weeks
    Intervention: Drug: etravirine
  • Experimental: 2
    patients treats with efavirenz for 6 weeks
    Intervention: Drug: efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2009
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients > 18 years
  • Signing the study consent form and agree to change ART regimen
  • Stable HAART including EFV since at least 3 months
  • HIV-RNA below 50 copies for at least 3 months

Exclusion Criteria:

  • No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV
  • Mentally incompetent patients
  • Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.
  • Concomitant renal or hepatic disease:

    • Creatinine above 150 micromol/L
    • Transaminases above 5 times upper normal limit
    • Prothrombin (Quick) value below 50%
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00792584
08-136
Yes
Alain Nguyen, Dr, University Hospital, Geneva
University Hospital, Geneva
  • University of Bern
  • University of Lausanne Hospitals
  • Hospital Lugano
  • University Hospital, Basel, Switzerland
  • Hospital of Neuchâtel
Principal Investigator: Bernard BH Hirschel, Professor Geneva Hospital
University Hospital, Geneva
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP