NCT00944957

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

Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (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 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.

Conditions

• Sleep Disorders
• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir for the first 2 weeks	Patient receives raltegravir and efavirenz placebo during the first 2 weeks
DRUG	Efavirenz for the last 2 weeks	Patient receives efavirenz and raltegravir placebo during the last 2 weeks
DRUG	Efavirenz for the first 2 weeks	Efavirenz and raltegravir placebo for the first 2 weeks
DRUG	Raltegravir for the last 2 weeks	Raltegravir and efavirenz placebo for the last 2 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-12-01
• Completion: 2010-04-01
• First posted: 2009-07-23
• Last updated: 2010-01-12

Locations

1 site across 1 country: Switzerland