NCT00792584

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Disorders

Interventions

Type	Name	Description
DRUG	etravirine	Patient receives etravirine/ placebo or efavirenz / placebo
DRUG	efavirenz	patient receives efavirenz / placebo or etravirine / placebo

Timeline

• Start date: 2008-11-01
• Primary completion: 2008-11-01
• Completion: 2009-06-01
• First posted: 2008-11-18
• Last updated: 2011-09-12

Locations

1 site across 1 country: Switzerland