Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
University Hospital, Geneva
Collaborators:
Hospital Lugano Hospital of Neuchâtel University Hospital, Basel, Switzerland University of Bern University of Lausanne Hospitals