Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476424
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2007-05-20
Brief Title:
A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2020-07
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:
A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects
Detailed Description:
Efavirenz Pharmacokinetic evaluation supports once-daily dosing T12 is 10-52 hours The recommended dosage of efavirenz in combination with nucleoside reverse transcriptase inhibitor NRTI andor protease inhibitor PI is 600mg orally once daily
In Thai populations many ARV levels are very high We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg
In Thai populations many ARV levels are very high We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg
Study Oversight
Has Oversight DMC:
None
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?:
None