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

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

Conditions
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Sleep Disorders, HIV Infections

Intervention / Treatment
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* Drug: Raltegravir for the first 2 weeks
* Drug: Efavirenz for the last 2 weeks
* Drug: Efavirenz for the first 2 weeks
* Drug: Raltegravir for the last 2 weeks


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: Raltegravir first<br>Patients treated with Raltegravir for first 2 weeks | Drug: Raltegravir for the first 2 weeks<br>* Patient receives raltegravir and efavirenz placebo during the first 2 weeks<br>Drug: Efavirenz for the last 2 weeks<br>* Patient receives efavirenz and raltegravir placebo during the last 2 weeks<br>|
| Experimental: Efavirenz first<br>Patients treated with Efavirenz for first 2 weeks | Drug: Efavirenz for the first 2 weeks<br>* Efavirenz and raltegravir placebo for the first 2 weeks<br>Drug: Raltegravir for the last 2 weeks<br>* Raltegravir and efavirenz placebo for the last 2 weeks<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 2 and week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of daytime sleepiness |  | baseline, week 2 and week 4 | 
| Sleep Quality |  | baseline, week 2 and week 4 | 
| Patient preference |  | 4 weeks | 
| Symptoms of depression, anxiety and stress will be assessed |  | baseline, week 2 and week 4 | 

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