Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT00556634
Status:
COMPLETED
Last Update Posted:
2009-01-15
First Post:
2007-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
Sponsor:
Sociedad Andaluza de Enfermedades Infecciosas
Organization:
Study Overview
Official Title:
Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients.
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: