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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
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

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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Symptoms and neurological side effects of study drugs [ Time Frame: baseline, week 2 and week 4 ]

Secondary Outcome Measures :
  1. Levels of daytime sleepiness [ Time Frame: baseline, week 2 and week 4 ]
  2. Sleep Quality [ Time Frame: baseline, week 2 and week 4 ]
  3. Patient preference [ Time Frame: 4 weeks ]
  4. 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, Older Adult)
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%

Information from the National Library of Medicine

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


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

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