Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Disorders; HIV Infections
Intervention: Raltegravir for the first 2 weeks (Drug); Efavirenz for the last 2 weeks (Drug); Efavirenz for the first 2 weeks (Drug); Raltegravir for the last 2 weeks (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Geneva Official(s) and/or principal investigator(s): Bernard BH Hirschel, Professor, Principal Investigator, Affiliation: Geneva Hospital
Overall contact: Bernard BH Hirschel, Professor, Phone: 022 372 98 11, Ext: +41, Email: bernard.hirschel@hcuge.ch
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.
Clinical Details
Official title: Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Symptoms and neurological side effects of study drugs
Secondary outcome: Levels of daytime sleepinessSleep Quality Patient preference Symptoms of depression, anxiety and stress will be assessed
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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%
Locations and Contacts
Bernard BH Hirschel, Professor, Phone: 022 372 98 11, Ext: +41, Email: bernard.hirschel@hcuge.ch
University Hopistal of Geneva, Geneva 1211, Switzerland; Recruiting Bernard BH Hirschel, Professor, Phone: 022 372 98 11, Ext: +41, Email: bernard.hirschel@hcuge.ch
Additional Information
Swiss HIV Cohort Study Homepage Bernard Hirschel
Starting date: November 2009
Last updated: January 11, 2010
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