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

University Hospitals (UH)

Status: Unknown

Conditions: Sleep Disorders; HIV Infections

Treatments: Drug: Raltegravir for the first 2 weeks; Drug: Efavirenz for the last 2 weeks; Drug: Raltegravir for the last 2 weeks; Drug: Efavirenz for the first 2 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT00944957

IEC 09-087

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Raltegravir first

Experimental group

Description:

Patients treated with Raltegravir for first 2 weeks

Treatment:

Drug: Raltegravir for the first 2 weeks

Drug: Efavirenz for the last 2 weeks

Efavirenz first

Experimental group

Description:

Patients treated with Efavirenz for first 2 weeks

Treatment:

Drug: Raltegravir for the last 2 weeks

Drug: Efavirenz for the first 2 weeks