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

HIV Infections Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00944957
• Other study ID #: IEC 09-087
• Status: Unknown status
• Phase: N/A
• First received: July 21, 2009
• Last updated: January 11, 2010
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: July 2009
• Source: University Hospital, Geneva
• Contact: Bernard BH Hirschel, Professor
• Phone: 022 372 98 11
• Email: bernard.hirschel[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Depression
• HIV Infections
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• Raltegravir for the first 2 weeks
Patient receives raltegravir and efavirenz placebo during the first 2 weeks
• Efavirenz for the last 2 weeks
Patient receives efavirenz and raltegravir placebo during the last 2 weeks
• Efavirenz for the first 2 weeks
Efavirenz and raltegravir placebo for the first 2 weeks
• Raltegravir for the last 2 weeks
Raltegravir and efavirenz placebo for the last 2 weeks

Locations

Country	Name	City	State
Switzerland	University Hopistal of Geneva	Geneva

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Geneva	Hospital Lugano, Hospital of Neuchâtel, University Hospital, Basel, Switzerland, University Hospital, Zürich, University of Bern, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms and neurological side effects of study drugs		baseline, week 2 and week 4
Secondary	Levels of daytime sleepiness		baseline, week 2 and week 4
Secondary	Sleep Quality		baseline, week 2 and week 4
Secondary	Patient preference		4 weeks
Secondary	Symptoms of depression, anxiety and stress will be assessed		baseline, week 2 and week 4

External Links

•   Homepage Bernard Hirschel
•   Swiss HIV Cohort Study