Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476853
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2007-05-20
Brief Title:
Efficacy Safety Study Comparing 2 Doses of NVP After Initiating Rifampin-containing TB Therapy
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
A 48 Week Randomized Open-label 2 Arm Study to Compare the Efficacy Safety and Tolerability of HAART Containing Nevirapine 400mgDay Versus Nevirapine 600 mgDay in HIV-1 Infected Patients Started at 2-6 Weeks After Initiating Rifampin Containing Antituberculous Therapy
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 48 week randomized open-label two arm study to compare the efficacy safety and tolerability of HAART containing nevirapine 400 mgday versus nevirapine 600 mgday in HIV-1 infected patients started at 2-6 weeks after initiating rifampicin containing antituberculosis therapy
Detailed Description:
Preliminary data from the HIVNAT PK laboratory indicate that out of 560 patients treated with nevirapine 200 mg bid and rifampicin had sub-therapeutic nevirapine levels 30 mg mgL In a control group of 38 patients using nevirapine without rifampicin there were no sub-therapeutic levels A dose increase of nevirapine while patients who are receiving that rifampicin may be required Both nevirapine and rifampicin are tepatotoxic agents as are other agents used in treatment of HIV or tuberculosis Using a higher nevirapine may prevent the occurrence of sub-therapeutic nevirapine levels but may also induce more liver toxicity To address these issues we designed a randomized prospective study to evaluate the safety efficacy and pharmacokinetics of nevirapine 400 mgday versus 600 mgday with a two weeks lead-in 200 mgday and 400 mgday respectively in TB-HIV co-infected patients who taking rifampicin and short-term efficacy and toxicity
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