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Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz (Switch-ER)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by University Hospital, Geneva.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University Hospital, Geneva
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
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Purpose
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 | Intervention |
|---|---|
| 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz |
Resource links provided by NLM:
Further study details as provided by University Hospital, Geneva:
Primary Outcome Measures:
- Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 2 and week 4 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Raltegravir first
Patients treated with Raltegravir for first 2 weeks
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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%
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944957
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944957
Contacts
| Contact: Bernard BH Hirschel, Professor | 022 372 98 11 ext +41 | bernard.hirschel@hcuge.ch |
Locations
| Switzerland | |
| University Hopistal of Geneva | Recruiting |
| Geneva, Switzerland, 1211 | |
| Contact: Bernard BH Hirschel, Professor 022 372 98 11 ext +41 bernard.hirschel@hcuge.ch | |
Sponsors and Collaborators
University Hospital, Geneva
University of Bern
University of Lausanne Hospitals
Hospital Lugano
University Hospital, Basel, Switzerland
Hospital of Neuchâtel
University Hospital, Zürich
Investigators
| Principal Investigator: | Bernard BH Hirschel, Professor | Geneva Hospital |
More Information
Additional Information:
| Responsible Party: | Professeur Bernard Hirschel, Geneva infectious diseases |
| ClinicalTrials.gov Identifier: | NCT00944957 History of Changes |
| Other Study ID Numbers: |
IEC 09-087 |
| Study First Received: | July 21, 2009 |
| Last Updated: | January 11, 2010 |
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 |
ClinicalTrials.gov processed this record on July 26, 2017