Clinical trial NCT00792584: Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Official title: Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Bern
name: University of Lausanne Hospitals
name: Hospital Lugano
name: University Hospital, Basel, Switzerland
name: Hospital of Neuchâtel
First posted: 2008-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%

Primary outcomes:
measure: Symptoms and neurological side effects of study drugs
timeFrame: baseline, week 6 and week 12
Secondary outcomes:
measure: Levels of daytime sleepiness
timeFrame: baseline, week 6 and week 12
measure: Sleep Quality
timeFrame: baseline, week 6 and week 12
measure: Patient preference
timeFrame: 12 weeks
measure: Symptoms of depression, anxiety and stress will be assessed
timeFrame: baseline, week 6 and week 12
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva Hospital
Study officials:
affiliation: Geneva Hospital
name: Bernard BH Hirschel, Professor
role: PRINCIPAL_INVESTIGATOR
References: