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

Primary Purpose

Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
etravirine
efavirenz
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Geneva Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

patients treats with etravirine for 6 weeks

patients treats with efavirenz for 6 weeks

Outcomes

Primary Outcome Measures

Symptoms and neurological side effects of study drugs

Secondary Outcome Measures

Levels of daytime sleepiness
Sleep Quality
Patient preference
Symptoms of depression, anxiety and stress will be assessed

Full Information

First Posted
November 17, 2008
Last Updated
September 9, 2011
Sponsor
University Hospital, Geneva
Collaborators
University of Bern, University of Lausanne Hospitals, Hospital Lugano, University Hospital, Basel, Switzerland, Hospital of Neuchâtel
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1. Study Identification

Unique Protocol Identification Number
NCT00792584
Brief Title
Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Acronym
SWITCH-EE
Official Title
Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
Collaborators
University of Bern, University of Lausanne Hospitals, Hospital Lugano, University Hospital, Basel, Switzerland, Hospital of Neuchâtel

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients treats with etravirine for 6 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
patients treats with efavirenz for 6 weeks
Intervention Type
Drug
Intervention Name(s)
etravirine
Intervention Description
Patient receives etravirine/ placebo or efavirenz / placebo
Intervention Type
Drug
Intervention Name(s)
efavirenz
Intervention Description
patient receives efavirenz / placebo or etravirine / placebo
Primary Outcome Measure Information:
Title
Symptoms and neurological side effects of study drugs
Time Frame
baseline, week 6 and week 12
Secondary Outcome Measure Information:
Title
Levels of daytime sleepiness
Time Frame
baseline, week 6 and week 12
Title
Sleep Quality
Time Frame
baseline, week 6 and week 12
Title
Patient preference
Time Frame
12 weeks
Title
Symptoms of depression, anxiety and stress will be assessed
Time Frame
baseline, week 6 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard BH Hirschel, Professor
Organizational Affiliation
Geneva Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva Hospital
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.shcs.ch
Description
Swiss HIV Cohort Study

Learn more about this trial

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

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