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

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; Sleep Disorders
• Intervention / Treatment: 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
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • University Hopistal of Geneva
    • Contact: Bernard BH Hirschel, Professor; Phone Number: +41 022 372 98 11; Email: bernard.hirschel@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptoms and neurological side effects of study drugs	baseline, week 2 and week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Levels of daytime sleepiness	baseline, week 2 and week 4
Sleep Quality	baseline, week 2 and week 4
Patient preference	4 weeks
Symptoms of depression, anxiety and stress will be assessed	baseline, week 2 and week 4

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: University Hospital, Basel, Switzerland; University of Lausanne Hospitals; University of Bern; University Hospital, Zürich; Hospital Lugano; Hospital of Neuchâtel
• Investigators: Principal Investigator: Bernard BH Hirschel, Professor, Geneva Hospital

Publications and helpful links

Helpful Links

• Swiss HIV Cohort Study
• Homepage Bernard Hirschel

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): January 12, 2010
• Last Update Submitted That Met QC Criteria: January 11, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: HIV; depression; compliance; anxiety; treatment experienced; efavirenz; sleep quality; Raltegravir; NNRTI; Tritherapy; stocrin
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Depression; Sleep Wake Disorders; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; HIV Integrase Inhibitors; Integrase Inhibitors; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Raltegravir Potassium; Efavirenz
• Other Study ID Numbers: IEC 09-087