Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483054
Status:
COMPLETED
Last Update Posted:
2011-11-22
First Post:
2007-06-05
Brief Title:
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Sponsor:
Bamrasnaradura Infectious Diseases Institute
Organization:
Bamrasnaradura Infectious Diseases Institute
Study Overview
Official Title:
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Status:
COMPLETED
Status Verified Date:
2009-06
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:
N2R
Brief Summary:
The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment All patients receive the same backbone regimen of stavudine 30 mg40 mg twice daily lamivudie 150 mg twice daily They are randomized to receive nevirapine 400 mgday twice daily vs efavirenz 600 mgday at bed time All patients are followed through 144 weeks after initiation of antiviral therapy The primary objective are to compare the proportion of patient who achieve undetectable plasma HIV-1RNA50 copiesml at week 48 The previous reports demonstrated that the standard doses of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis patients who receiving rifampicin even though plasma levels are somewhat reduced by rifampicin However there have been not been a randomized control trial to compare these two regimens Thus this trial will provide the efficacy data between these two regimens
Detailed Description:
None
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