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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Disorders

Intervention / Treatment
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* Drug: etravirine
* Drug: efavirenz


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients treats with etravirine for 6 weeks | Drug: etravirine<br>* Patient receives etravirine/ placebo or efavirenz / placebo<br>|
| Experimental: 2<br>patients treats with efavirenz for 6 weeks | Drug: efavirenz<br>* patient receives efavirenz / placebo or etravirine / placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and neurological side effects of study drugs |  | baseline, week 6 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etravirine, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy, 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, compliance