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
  Purpose

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.


Condition Intervention
Sleep Disorders
Drug: etravirine
Drug: efavirenz

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients treats with etravirine for 6 weeks
Drug: etravirine
Patient receives etravirine/ placebo or efavirenz / placebo
Experimental: 2
patients treats with efavirenz for 6 weeks
Drug: efavirenz
patient receives efavirenz / placebo or etravirine / placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  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: NCT00792584

Locations
Switzerland
Geneva Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
University of Bern
University of Lausanne Hospitals
Hospital Lugano
University Hospital, Basel, Switzerland
Hospital of Neuchâtel
Investigators
Principal Investigator: Bernard BH Hirschel, Professor Geneva Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Alain Nguyen, Dr, Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00792584     History of Changes
Other Study ID Numbers: 08-136
Study First Received: November 17, 2008
Last Updated: September 9, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
etravirine
efavirenz
anxiety
depression
sleep quality
HIV
NNRTI
Tritherapy
compliance
stocrin
To replace efavirenz in long-term users with etravirine
To investigate effect of such replacement on patient preference, sleep quality, daytime sleepiness, and anxiety

Additional relevant MeSH terms:
Depression
Depressive Disorder
Parasomnias
Sleep Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Efavirenz
Etravirine
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 21, 2014