Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz (Switch-ER)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Bern
University of Lausanne Hospitals
Hospital Lugano
University Hospital, Basel, Switzerland
Hospital of Neuchâtel
University Hospital, Zürich
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00944957
First received: July 21, 2009
Last updated: January 11, 2010
Last verified: July 2009

July 21, 2009
January 11, 2010
November 2009
December 2009   (final data collection date for primary outcome measure)
Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00944957 on ClinicalTrials.gov Archive Site
  • Levels of daytime sleepiness [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]
  • Sleep Quality [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]
  • Patient preference [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Symptoms of depression, anxiety and stress will be assessed [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir 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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Sleep Disorders
  • HIV Infections
  • Drug: Raltegravir for the first 2 weeks
    Patient receives raltegravir and efavirenz placebo during the first 2 weeks
  • Drug: Efavirenz for the last 2 weeks
    Patient receives efavirenz and raltegravir placebo during the last 2 weeks
  • Drug: Efavirenz for the first 2 weeks
    Efavirenz and raltegravir placebo for the first 2 weeks
  • Drug: Raltegravir for the last 2 weeks
    Raltegravir and efavirenz placebo for the last 2 weeks
  • Experimental: Raltegravir first
    Patients treated with Raltegravir for first 2 weeks
    Interventions:
    • Drug: Raltegravir for the first 2 weeks
    • Drug: Efavirenz for the last 2 weeks
  • Experimental: Efavirenz first
    Patients treated with Efavirenz for first 2 weeks
    Interventions:
    • Drug: Efavirenz for the first 2 weeks
    • Drug: Raltegravir for the last 2 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2010
December 2009   (final data collection date for primary outcome measure)

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%
Both
18 Years and older
No
Contact: Bernard BH Hirschel, Professor 022 372 98 11 ext +41 bernard.hirschel@hcuge.ch
Switzerland
 
NCT00944957
IEC 09-087
Yes
Professeur Bernard Hirschel, Geneva infectious diseases
University Hospital, Geneva
  • University of Bern
  • University of Lausanne Hospitals
  • Hospital Lugano
  • University Hospital, Basel, Switzerland
  • Hospital of Neuchâtel
  • University Hospital, Zürich
Principal Investigator: Bernard BH Hirschel, Professor Geneva Hospital
University Hospital, Geneva
July 2009

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