Sleep DisordersSwitch-ERNCT00944957
Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz
A study testing Raltegravir for the first 2 weeks, Efavirenz for the last 2 weeks and Efavirenz for the first 2 weeks in people with Sleep Disorders and HIV Infections, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorders, HIV Infections
- What is being tested?
- Raltegravir for the first 2 weeks, Efavirenz for the last 2 weeks and Efavirenz for the first 2 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hopistal of Geneva
Geneva, Canton of Geneva, 1211
Bernard BH Hirschel, Professor, 022 372 98 11 ext. +41, bernard.hirschel@hcuge.ch
About this study
Official title: 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.
- Conditions
- Sleep Disorders, HIV Infections
- Being tested
- Raltegravir for the first 2 weeks, Efavirenz for the last 2 weeks, Efavirenz for the first 2 weeks, Raltegravir for the last 2 weeks
- Keywords
- Raltegravir, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy, compliance, stocrin, treatment experienced
- Medical subject headings
- Sleep Wake Disorders, HIV Infections, Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir for the first 2 weeksDrug
Patient receives raltegravir and efavirenz placebo during the first 2 weeks
Efavirenz for the last 2 weeksDrug
Patient receives efavirenz and raltegravir placebo during the last 2 weeks
Efavirenz for the first 2 weeksDrug
Efavirenz and raltegravir placebo for the first 2 weeks
Raltegravir for the last 2 weeksDrug
Raltegravir and efavirenz placebo for the last 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir first | Experimental | Patients treated with Raltegravir for first 2 weeks Receives: Drug: Raltegravir for the first 2 weeks; Drug: Efavirenz for the last 2 weeks |
| Efavirenz first | Experimental | Patients treated with Efavirenz for first 2 weeks Receives: Drug: Efavirenz for the first 2 weeks; Drug: Raltegravir for the last 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and neurological side effects of study drugs
Measured: baseline, week 2 and week 4
Secondary outcomes (4)
Levels of daytime sleepiness
Measured: baseline, week 2 and week 4
Sleep Quality
Measured: baseline, week 2 and week 4
Patient preference
Measured: 4 weeks
Symptoms of depression, anxiety and stress will be assessed
Measured: baseline, week 2 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2009 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, University of Lausanne Hospitals, Hospital Lugano, University Hospital, Basel, Switzerland, Hospital of Neuchâtel, University Hospital, Zürich
- Investigators
- Bernard BH Hirschel, Professor, Principal investigator, Geneva Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944957
- Sponsor's protocol ID
- IEC 09-087
- Acronym
- Switch-ER
- Status last verified
- Jul 2009
- First submitted
- 21 Jul 2009
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz
- ClinicalTrials.gov ID
- NCT00944957
- Acronym / sponsor ID
- Switch-ER / IEC 09-087
- Conditions
- Sleep Disorders, HIV Infections
- Keywords
- Raltegravir, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Bern, University of Lausanne Hospitals, Hospital Lugano, University Hospital, Basel, Switzerland, Hospital of Neuchâtel, University Hospital, Zürich
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir first | Experimental | Drug: Raltegravir for the first 2 weeks, Drug: Efavirenz for the last 2 weeksPatients treated with Raltegravir for first 2 weeks |
| Efavirenz first | Experimental | Drug: Efavirenz for the first 2 weeks, Drug: Raltegravir for the last 2 weeksPatients treated with Efavirenz for first 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raltegravir for the first 2 weeksPatient receives raltegravir and efavirenz placebo during the first 2 weeks | Drug | Raltegravir first |
| Efavirenz for the last 2 weeksPatient receives efavirenz and raltegravir placebo during the last 2 weeks | Drug | Raltegravir first |
| Efavirenz for the first 2 weeksEfavirenz and raltegravir placebo for the first 2 weeks | Drug | Efavirenz first |
| Raltegravir for the last 2 weeksRaltegravir and efavirenz placebo for the last 2 weeks | Drug | Efavirenz first |
Primary outcome
Symptoms and neurological side effects of study drugs
Time frame: baseline, week 2 and week 4
4 secondary outcomes
Levels of daytime sleepiness
Time frame: baseline, week 2 and week 4
Sleep Quality
Time frame: baseline, week 2 and week 4
Patient preference
Time frame: 4 weeks
Symptoms of depression, anxiety and stress will be assessed
Time frame: baseline, week 2 and week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Swiss HIV Cohort StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard BH Hirschel, Professor principal investigator
Geneva Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raltegravir for the first 2 weeks, Efavirenz for the last 2 weeks and Efavirenz for the first 2 weeks in people with Sleep Disorders and HIV Infections, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernard BH Hirschel, Professor (022 372 98 11 ext. +41, bernard.hirschel@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms and neurological side effects of study drugs (time frame: baseline, week 2 and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.