Status:
COMPLETED
Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
University of Bern
University of Lausanne Hospitals
Conditions:
Sleep Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00792584
Start Date
November 1 2008
End Date
June 1 2009
Last Update
September 12 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Geneva Hospital
Geneva, Canton of Geneva, Switzerland, 1211