Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513379
Status:
UNKNOWN
Last Update Posted:
2020-08-14
First Post:
2020-08-12
Brief Title:
Efficacy of 400 mg Efavirenz Versus Standard 600 mg Dose in HIVTB Co-infected Patients
Sponsor:
Shanghai Public Health Clinical Center
Organization:
Shanghai Public Health Clinical Center
Study Overview
Official Title:
Efficacy and Safety of 400 mg Efavirenz Versus Standard 600 mg Dose in HIVTB Co-infected Patients Receiving Rifampicin Based Anti-TB Therapy
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
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:
TB is the most common cause of death in patients with HIV worldwide Rifampicin RIF is the cornerstone of anti-TB therapy Current guideline recommend efavirenz EFV 600mg per day as the first of choice for HIVTB co-infection Co-administration of EFV with RIF decrease the plasma concentration of EFV Because of better safety profiles EFV 400mg has replaced the EFV 600mg as the first-line antiretroviral therapy in people living with HIV However the efficacy of EFV 400mg when co-administrated with RIF in HIVTB co-infection is unclear This study is designed to evaluate the efficacy and safety of EFV 400mg versus EFV 600mg in HIVTB co-infected patients receiving RIF based anti-TB therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None