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

Not Applicable

• Conditions: Sleep Disorders; HIV Infections
• Interventions: Drug: Raltegravir for the first 2 weeks; Drug: Efavirenz for the first 2 weeks; Drug: Efavirenz for the last 2 weeks; Drug: Raltegravir for the last 2 weeks

• Registration Number: NCT00944957
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Study Start: 2009-11
• Primary Completion: 2009-12
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Raltegravir first	Raltegravir for the first 2 weeks	Patients treated with Raltegravir for first 2 weeks
Raltegravir first	Efavirenz for the last 2 weeks	Patients treated with Raltegravir for first 2 weeks
Efavirenz first	Efavirenz for the first 2 weeks	Patients treated with Efavirenz for first 2 weeks
Efavirenz first	Raltegravir for the last 2 weeks	Patients treated with Efavirenz for first 2 weeks

Primary Outcome Measures

Name	Time	Method
Symptoms and neurological side effects of study drugs	baseline, week 2 and week 4

Secondary Outcome Measures

Name	Time	Method
Levels of daytime sleepiness	baseline, week 2 and week 4
Sleep Quality	baseline, week 2 and week 4
Patient preference	4 weeks
Symptoms of depression, anxiety and stress will be assessed	baseline, week 2 and week 4

Trial Locations

Locations (1)

University Hopistal of Geneva; 🇨🇭 Geneva, Switzerland