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

Primary Purpose

Sleep Disorders, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Raltegravir for the first 2 weeks
Efavirenz for the last 2 weeks
Efavirenz for the first 2 weeks
Raltegravir for the last 2 weeks
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders focused on measuring Raltegravir, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy, compliance, stocrin, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • University Hopistal of GenevaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Raltegravir first

Efavirenz first

Arm Description

Patients treated with Raltegravir for first 2 weeks

Patients treated with Efavirenz for first 2 weeks

Outcomes

Primary Outcome Measures

Symptoms and neurological side effects of study drugs

Secondary Outcome Measures

Levels of daytime sleepiness
Sleep Quality
Patient preference
Symptoms of depression, anxiety and stress will be assessed

Full Information

First Posted
July 21, 2009
Last Updated
January 11, 2010
Sponsor
University Hospital, Geneva
Collaborators
University of Bern, University of Lausanne Hospitals, Hospital Lugano, University Hospital, Basel, Switzerland, Hospital of Neuchâtel, University Hospital, Zürich
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1. Study Identification

Unique Protocol Identification Number
NCT00944957
Brief Title
Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
Acronym
Switch-ER
Official Title
Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva
Collaborators
University of Bern, University of Lausanne Hospitals, Hospital Lugano, University Hospital, Basel, Switzerland, Hospital of Neuchâtel, University Hospital, Zürich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, HIV Infections
Keywords
Raltegravir, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy, compliance, stocrin, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir first
Arm Type
Experimental
Arm Description
Patients treated with Raltegravir for first 2 weeks
Arm Title
Efavirenz first
Arm Type
Experimental
Arm Description
Patients treated with Efavirenz for first 2 weeks
Intervention Type
Drug
Intervention Name(s)
Raltegravir for the first 2 weeks
Intervention Description
Patient receives raltegravir and efavirenz placebo during the first 2 weeks
Intervention Type
Drug
Intervention Name(s)
Efavirenz for the last 2 weeks
Intervention Description
Patient receives efavirenz and raltegravir placebo during the last 2 weeks
Intervention Type
Drug
Intervention Name(s)
Efavirenz for the first 2 weeks
Intervention Description
Efavirenz and raltegravir placebo for the first 2 weeks
Intervention Type
Drug
Intervention Name(s)
Raltegravir for the last 2 weeks
Intervention Description
Raltegravir and efavirenz placebo for the last 2 weeks
Primary Outcome Measure Information:
Title
Symptoms and neurological side effects of study drugs
Time Frame
baseline, week 2 and week 4
Secondary Outcome Measure Information:
Title
Levels of daytime sleepiness
Time Frame
baseline, week 2 and week 4
Title
Sleep Quality
Time Frame
baseline, week 2 and week 4
Title
Patient preference
Time Frame
4 weeks
Title
Symptoms of depression, anxiety and stress will be assessed
Time Frame
baseline, week 2 and week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard BH Hirschel, Professor
Phone
022 372 98 11
Ext
+41
Email
bernard.hirschel@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard BH Hirschel, Professor
Organizational Affiliation
Geneva Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hopistal of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard BH Hirschel, Professor
Phone
022 372 98 11
Ext
+41
Email
bernard.hirschel@hcuge.ch

12. IPD Sharing Statement

Links:
URL
http://www.shcs.ch
Description
Swiss HIV Cohort Study

Learn more about this trial

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

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