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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00792584

Acronym

SWITCH-EE

Enrollment

Registered

2008-11-18

Start date

2008-11-30

Completion date

2009-06-30

Last updated

2011-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Keywords

etravirine, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy, compliance, stocrin, To replace efavirenz in long-term users with etravirine, To investigate effect of such replacement on patient preference, sleep quality, daytime sleepiness, and anxiety

Brief 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.

Interventions

DRUGetravirine

Patient receives etravirine/ placebo or efavirenz / placebo

DRUGefavirenz

patient receives efavirenz / placebo or etravirine / placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
Symptoms and neurological side effects of study drugs	baseline, week 6 and week 12

Secondary

Measure	Time frame
Levels of daytime sleepiness	baseline, week 6 and week 12
Sleep Quality	baseline, week 6 and week 12
Patient preference	12 weeks
Symptoms of depression, anxiety and stress will be assessed	baseline, week 6 and week 12

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026