Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz (SWITCH-EE)
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.
|Study Design:||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|
- Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 6 and week 12 ]
- Levels of daytime sleepiness [ Time Frame: baseline, week 6 and week 12 ]
- Sleep Quality [ Time Frame: baseline, week 6 and week 12 ]
- Patient preference [ Time Frame: 12 weeks ]
- Symptoms of depression, anxiety and stress will be assessed [ Time Frame: baseline, week 6 and week 12 ]
|Study Start Date:||November 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
patients treats with etravirine for 6 weeks
Patient receives etravirine/ placebo or efavirenz / placebo
patients treats with efavirenz for 6 weeks
patient receives efavirenz / placebo or etravirine / placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792584
|Geneva, Switzerland, 1211|
|Principal Investigator:||Bernard BH Hirschel, Professor||Geneva Hospital|