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

Sleep Disorders Clinical Trial

— SWITCH-EE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792584
• Other study ID #: 08-136
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: September 9, 2011
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2011
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients > 18 years

• Signing the study consent form and agree to change ART regimen

• Stable HAART including EFV since at least 3 months

• HIV-RNA below 50 copies for at least 3 months

Exclusion Criteria:

• No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV

• Mentally incompetent patients

• Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.

• Concomitant renal or hepatic disease:

• Creatinine above 150 micromol/L

• Transaminases above 5 times upper normal limit

• Prothrombin (Quick) value below 50%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders

Intervention

Drug:
• etravirine
Patient receives etravirine/ placebo or efavirenz / placebo
• efavirenz
patient receives efavirenz / placebo or etravirine / placebo

Locations

Country	Name	City	State
Switzerland	Geneva Hospital	Geneva

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Geneva	Hospital Lugano, Hospital of Neuchâtel, University Hospital, Basel, Switzerland, University of Bern, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms and neurological side effects of study drugs		baseline, week 6 and week 12	Yes
Secondary	Levels of daytime sleepiness		baseline, week 6 and week 12	Yes
Secondary	Sleep Quality		baseline, week 6 and week 12	Yes
Secondary	Patient preference		12 weeks	No
Secondary	Symptoms of depression, anxiety and stress will be assessed		baseline, week 6 and week 12	Yes

External Links

•   Homepage Bernard Hirschel
•   Swiss HIV Cohort Study