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

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ClinicalTrials.gov Identifier: NCT00792584
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : September 12, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment
Sleep Disorders Drug: etravirine Drug: efavirenz

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Study Start Date : November 2008
Primary Completion Date : November 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 6 and week 12 ]

Secondary Outcome Measures :
  1. Levels of daytime sleepiness [ Time Frame: baseline, week 6 and week 12 ]
  2. Sleep Quality [ Time Frame: baseline, week 6 and week 12 ]
  3. Patient preference [ Time Frame: 12 weeks ]
  4. Symptoms of depression, anxiety and stress will be assessed [ Time Frame: baseline, week 6 and week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Alain Nguyen, Dr, Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00792584     History of Changes
Other Study ID Numbers: 08-136
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: September 12, 2011
Last Verified: September 2011

Keywords provided by Alain Nguyen, Dr, 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
Sleep Wake Disorders
Parasomnias
Behavioral Symptoms
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Efavirenz
Etravirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers