Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage

PHASE4CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
HIV-1 InfectionHIV Infection
Interventions
DRUG

Efavirenz

"Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward)~OR~Efavirenz usual dosage (600 mg/day from the first day)"

Trial Locations (10)

41013

Hospitales Universitarios Virgen del Rocio, Seville

Unknown

Hospital Torrecardenas, Almería

Hospital Universitario Puerta del Mar, Cadiz

Hospital de Jerez, Jerez de la Frontera

Hospital Universitario Reina Sofía, Córdoba

Hospital Juan Ramon Jimenez, Huelva

Hospital Universitario Carlos Haya, Málaga

Hospital Universitario Virgen de la Victoria, Málaga

Hospital Universitario de Valme, Seville

Hospital Universitario Virgen Macarena, Seville

All Listed Sponsors
collaborator

Junta de Andalucia

OTHER_GOV

lead

Sociedad Andaluza de Enfermedades Infecciosas

NETWORK

NCT00556634 - Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage | Biotech Hunter | Biotech Hunter