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

NCT ID: NCT00792584

Last Updated: 2011-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-06-30

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 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.

Conditions

Sleep Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

patients treats with etravirine for 6 weeks

Group Type: EXPERIMENTAL

etravirine

Intervention Type: DRUG

Patient receives etravirine/ placebo or efavirenz / placebo

2

patients treats with efavirenz for 6 weeks

Group Type: EXPERIMENTAL

efavirenz

Intervention Type: DRUG

patient receives efavirenz / placebo or etravirine / placebo

Interventions

etravirine

Patient receives etravirine/ placebo or efavirenz / placebo

Intervention Type: DRUG

efavirenz

patient receives efavirenz / placebo or etravirine / placebo

Intervention Type: DRUG

Eligibility 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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Hospital Lugano

UNKNOWN

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Hospital of Neuchâtel

UNKNOWN

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Alain Nguyen, Dr

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard BH Hirschel, Professor

Role: PRINCIPAL_INVESTIGATOR

Geneva Hospital

Locations

Geneva Hospital

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Related Links

http://www.shcs.ch

Swiss HIV Cohort Study

Other Identifiers

08-136

Identifier Type: -

Identifier Source: org_study_id