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OpenTrials
Completed

NCT Number: NCT00792584

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

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.

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Key information

Conditions

Sleep Disorders Anxiety Disorders Behavior Behavioral Symptoms Depression Disorders of Excessive Somnolence Dyssomnias Health Behavior Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Etravirine

Drug

Patient receives etravirine/ placebo or efavirenz / placebo

Efavirenz

Drug

patient receives efavirenz / placebo or etravirine / placebo

Primary outcomes

  1. Symptoms and neurological side effects of study drugs

    Time frame: baseline, week 6 and week 12

Secondary outcomes

  1. Levels of daytime sleepiness

    Time frame: baseline, week 6 and week 12

  2. Sleep Quality

    Time frame: baseline, week 6 and week 12

  3. Patient preference

    Time frame: 12 weeks

  4. Symptoms of depression, anxiety and stress will be assessed

    Time frame: baseline, week 6 and week 12

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

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

Registry information

Acronym: SWITCH-EE

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Nov 18, 2008
Registry last updated
Sep 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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