Patient Preference, Sleep Quality, and Anxiety/Depression: A Randomized Comparison of Etravirine and Efavirenz (SWITCH-EE)

This study has been completed.

Sponsor:

Collaborators:

University of Bern

University of Lausanne Hospitals

Hospital Lugano

University Hospital, Basel, Switzerland

Hospital of Neuchâtel

Information provided by (Responsible Party):

Alain Nguyen, Dr, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT00792584

First received: November 17, 2008

Last updated: September 9, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2008

Last Updated Date

September 9, 2011

Start Date ^ICMJE

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00792584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Levels of daytime sleepiness [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
Sleep Quality [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]
Patient preference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Symptoms of depression, anxiety and stress will be assessed [ Time Frame: baseline, week 6 and week 12 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Sleep Disorders

Intervention ^ICMJE

Drug: etravirine
Patient receives etravirine/ placebo or efavirenz / placebo
Drug: efavirenz
patient receives efavirenz / placebo or etravirine / placebo

Study Arm (s)

Experimental: 1
patients treats with etravirine for 6 weeks

Intervention: Drug: etravirine
Experimental: 2
patients treats with efavirenz for 6 weeks

Intervention: Drug: efavirenz

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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%

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00792584

Other Study ID Numbers ^ICMJE

08-136

Has Data Monitoring Committee

Yes

Responsible Party

Alain Nguyen, Dr, University Hospital, Geneva

Study Sponsor ^ICMJE

University Hospital, Geneva

Collaborators ^ICMJE

University of Bern
University of Lausanne Hospitals
Hospital Lugano
University Hospital, Basel, Switzerland
Hospital of Neuchâtel

Investigators ^ICMJE

Principal Investigator:

Bernard BH Hirschel, Professor

Geneva Hospital

Information Provided By

University Hospital, Geneva

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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