Patient Preference, Sleep Quality, and Anxiety/Depression: A Comparison of Raltegravir and Efavirenz

Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944957

Acronym

Switch-ER

Enrollment

Registered

2009-07-23

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sleep Disorders

Keywords

Raltegravir, efavirenz, anxiety, depression, sleep quality, HIV, NNRTI, Tritherapy, compliance, stocrin, treatment experienced

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.

Interventions

DRUGRaltegravir for the first 2 weeks

Patient receives raltegravir and efavirenz placebo during the first 2 weeks

DRUGEfavirenz for the last 2 weeks

Patient receives efavirenz and raltegravir placebo during the last 2 weeks

DRUGEfavirenz for the first 2 weeks

Efavirenz and raltegravir placebo for the first 2 weeks

DRUGRaltegravir for the last 2 weeks

Raltegravir and efavirenz placebo for the last 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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%

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Contacts

Primary ContactBernard BH Hirschel, Professor

bernard.hirschel@hcuge.ch022 372 98 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026