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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Hospital, Geneva.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT00944957
First received: July 21, 2009
Last updated: January 11, 2010
Last verified: July 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Levels of daytime sleepiness [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]
  • Sleep Quality [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]
  • Patient preference [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Symptoms of depression, anxiety and stress will be assessed [ Time Frame: baseline, week 2 and week 4 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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

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:
No publications provided

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
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Raltegravir
efavirenz
anxiety
depression
sleep quality
HIV
NNRTI
Tritherapy
compliance
stocrin
treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Depression
Depressive Disorder
HIV Infections
Parasomnias
Sleep Disorders
Behavioral Symptoms
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Slow Virus Diseases
Virus Diseases
Efavirenz
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014