Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Sleep Disorders
Intervention
Raltegravir for the first 2 weeks, Efavirenz for the last 2 weeks, Efavirenz for the first 2 weeks, Raltegravir for the last 2 weeks
Location
University Hopistal of Geneva
Geneva
Switzerland
1211
Status
Recruiting
Source
University Hospital, Geneva
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00944957
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Fetal Mortality
Number of fetal deaths with stated or presumed gestation of 20 weeks or more in a given population. Late fetal mortality is death after of 28 weeks or more.
Pregnancy, Prolonged
A term used to describe pregnancies that exceed the upper limit of a normal gestational period. In humans, a prolonged pregnancy is defined as one that extends beyond 42 weeks (294 days) after the first day of the last menstrual period (MENSTRUATION), or birth with gestational age of 41 weeks or more.
Transmissible Gastroenteritis Virus
A species of CORONAVIRUS causing a fatal disease to pigs under 3 weeks old.
Term Birth
CHILDBIRTH at the end of a normal duration of PREGNANCY, between 37 to 40 weeks of gestation or about 280 days from the first day of the mother's last menstrual period.
Hepatitis Virus, Duck
Unassigned species, in the family PICORNAVIRIDAE, causing high mortality in ducklings 3 days to 3 weeks old.
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