Clinical trial NCT00944957: Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Official title: Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disorders
HIV Infections
Keywords: Raltegravir
efavirenz
anxiety
depression
sleep quality
HIV
NNRTI
Tritherapy
compliance
stocrin
treatment experienced
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
name: University Hospital, Zürich
First posted: 2009-07-23
Enrollment: 60
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 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.


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 2 and week 4
Secondary outcomes:
measure: Levels of daytime sleepiness
timeFrame: baseline, week 2 and week 4
measure: Sleep Quality
timeFrame: baseline, week 2 and week 4
measure: Patient preference
timeFrame: 4 weeks
measure: Symptoms of depression, anxiety and stress will be assessed
timeFrame: baseline, week 2 and week 4
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hopistal of Geneva
Study officials:
affiliation: Geneva Hospital
name: Bernard BH Hirschel, Professor
role: PRINCIPAL_INVESTIGATOR
References: