Who is sponsoring Switch-ER?

Switch-ER is sponsored by University Hospital, Geneva.

What condition does Switch-ER study?

Switch-ER studies Sleep Disorders, HIV Infections.

What drugs are being tested in Switch-ER?

Interventions: Raltegravir for the first 2 weeks, Efavirenz for the last 2 weeks, Efavirenz for the first 2 weeks, Raltegravir for the last 2 weeks.

What is the status of Switch-ER?

Switch-ER is currently UNKNOWN.

Last reviewed 2010-01-11 · How we verify

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

NCT00944957 NA UNKNOWN

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.

Details

Lead sponsor	University Hospital, Geneva
Phase	NA
Status	UNKNOWN
Enrolment	60
Start date	2009-11
Completion	2010-04

Conditions

Sleep Disorders
HIV Infections

Interventions

Raltegravir for the first 2 weeks
Efavirenz for the last 2 weeks
Efavirenz for the first 2 weeks
Raltegravir for the last 2 weeks

Primary outcomes

Symptoms and neurological side effects of study drugs — baseline, week 2 and week 4

Countries

Switzerland