Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Status:
Unknown status
Trial end date:
2010-04-01
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 four week, randomized, placebo-controlled, double-blind study. In
group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2,
efavirenz would be continued, and raltegravir placebo given in addition. After two 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 Hospital, Zürich University of Bern University of Lausanne Hospitals