Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz (Switch-ER)
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ClinicalTrials.gov Identifier: NCT00944957 |
Recruitment Status
: Unknown
Verified July 2009 by University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted
: July 23, 2009
Last Update Posted
: January 12, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Disorders HIV Infections | Drug: Raltegravir for the first 2 weeks Drug: Efavirenz for the last 2 weeks Drug: Efavirenz for the first 2 weeks Drug: Raltegravir for the last 2 weeks | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz |
Study Start Date : | November 2009 |
Estimated Primary Completion Date : | December 2009 |
Estimated Study Completion Date : | April 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Raltegravir first
Patients treated with Raltegravir for first 2 weeks
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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
|
Experimental: Efavirenz first
Patients treated with Efavirenz for first 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
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- Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 2 and week 4 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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Concomitant renal or hepatic disease:
- Creatinine above 150 micromol/L
- Transaminases above 5 times upper normal limit
- Prothrombin (Quick) value below 50%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944957
Contact: Bernard BH Hirschel, Professor | 022 372 98 11 ext +41 | bernard.hirschel@hcuge.ch |
Switzerland | |
University Hopistal of Geneva | Recruiting |
Geneva, Switzerland, 1211 | |
Contact: Bernard BH Hirschel, Professor 022 372 98 11 ext +41 bernard.hirschel@hcuge.ch |
Principal Investigator: | Bernard BH Hirschel, Professor | Geneva Hospital |
Additional Information:
Responsible Party: | Professeur Bernard Hirschel, Geneva infectious diseases |
ClinicalTrials.gov Identifier: | NCT00944957 History of Changes |
Other Study ID Numbers: |
IEC 09-087 |
First Posted: | July 23, 2009 Key Record Dates |
Last Update Posted: | January 12, 2010 |
Last Verified: | July 2009 |
Keywords provided by University Hospital, Geneva:
Raltegravir efavirenz anxiety depression sleep quality HIV |
NNRTI Tritherapy compliance stocrin treatment experienced |
Additional relevant MeSH terms:
Depression HIV Infections Sleep Wake Disorders Parasomnias Behavioral Symptoms Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nervous System Diseases Neurologic Manifestations |
Signs and Symptoms Mental Disorders Raltegravir Potassium Efavirenz Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors |