A randomized cross-over study to compare raltegravir and efavirenz (SWITCH-ER study)

AIDS. 2011 Jul 31;25(12):1481-7. doi: 10.1097/QAD.0b013e328348dab0.


Background: Efavirenz (EFV) causes neuropsychiatric side-effects and an unfavorable blood lipid profile. We investigated the effect of replacing EFV with raltegravir (RAL) on patient preference, daytime sleepiness, sleep quality, anxiety, and lipid levels.

Method: Switch-ER was a randomized, double-blind, cross-over study. Patients who tolerated EFV, with less than 50 copies/ml HIV-RNA, were randomized into two groups: the RAL-first group started with RAL (400 mg twice daily) and EFV placebo, and the EFV-first group with EFV (600 mg once daily) and RAL placebo. After 2 weeks, both groups switched to the alternate regimen. The primary endpoint was patient preference for the first or the second regimen, assessed after 4 weeks.

Results: Fifty seven participants were enrolled with a median CD4 cell count 600/μl, and duration of previous EFV therapy 3.4 years. Fifty three participants completed the study. When asked about treatment preference after 4 weeks, 22 preferred RAL and 12 preferred EFV, whereas 19 did not express a preference. A significant difference in anxiety and stress scores favoring RAL (P = 0.04 and 0.03, respectively) was observed. Median plasma cholesterol levels decreased by 0.4 mmol/l (16 mg/dl, P < 0.001), triglycerides by 0.2 mmol/l (18 mg/dl, P = 0.036), and low-density lipoprotein by 0.2 mmol/l (8 mg/dl, P = 0.004) after replacing EFV with RAL. After study completion, 51% of patients switched to RAL.

Conclusion: Half of patients previously on a stable EFV preferred to switch to RAL, after double-blind exposure to RAL for 2 weeks. Substitution of EFV by RAL significantly impacted on lipid levels, stress, and anxiety scores.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Alkynes
  • Antiretroviral Therapy, Highly Active
  • Anxiety Disorders / chemically induced
  • Anxiety Disorders / drug therapy*
  • Anxiety Disorders / psychology
  • Benzoxazines / administration & dosage*
  • Benzoxazines / adverse effects
  • CD4 Lymphocyte Count
  • Cross-Over Studies
  • Cyclopropanes
  • Drug Administration Schedule
  • Female
  • HIV Infections
  • HIV Protease Inhibitors / administration & dosage*
  • HIV Protease Inhibitors / adverse effects
  • HIV-1 / drug effects*
  • Humans
  • Male
  • Middle Aged
  • Practice Guidelines as Topic
  • Pyrrolidinones / administration & dosage*
  • Pyrrolidinones / adverse effects
  • Raltegravir Potassium
  • Sleep Initiation and Maintenance Disorders / chemically induced
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Sleep Initiation and Maintenance Disorders / psychology
  • Surveys and Questionnaires
  • Treatment Outcome


  • Alkynes
  • Benzoxazines
  • Cyclopropanes
  • HIV Protease Inhibitors
  • Pyrrolidinones
  • Raltegravir Potassium
  • efavirenz