Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081978
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2004-04-28
Brief Title:
TMC125-C223 TMC125 in HIV-1 Infected Subjects
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Randomized Controlled Partially Blinded Phase IIb Dose-Finding Trial of TMC125 in HIV-1 Infected Subjects With Documented Genotypic Evidence of Resistance to Currently Available NNRTIs and With at Least Three Primary PI Mutations
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the ability of TMC125 a Non-Nucleoside Reverse Transcriptase Inhibitor NNRTI to lower the amount of virus in your blood when administered twice daily for 48 weeks
Detailed Description:
TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor There are three treatment groups in the study One group will be given a dosage of TMC125 400 mg twice daily Another will be given 800 mg twice daily The third group a control arm will not receive TMC125 formulation TF035 The safety tolerability and pharmacokinetics determinations of the concentration of drug in your blood and its evolution over time of TMC125 will also be evaluated in this study Patients who have known resistance to NNRTIs and 3 or more protease inhibitor PI mutations may be eligible to participate One-hundred-fifty 150 patients will be enrolled into this study TMC125 400mg twice daily for 48 weeks TMC125 800mg twice daily for 48 weeks
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