Trial | NCT00792584  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Nov 30
2008
Primary Completion
Nov 30
2008
Study Completion
Jun 30
2009
Last Update
Sep 12
2011
Estimate

Drug etravirine

Patient receives etravirine/ placebo or efavirenz / placebo

Drug efavirenz

patient receives efavirenz / placebo or etravirine / placebo

1 Experimental

patients treats with etravirine for 6 weeks

2 Experimental

patients treats with efavirenz for 6 weeks

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%
No Results Posted