Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-28 @ 6:54 PM
Study NCT ID:
NCT00225303
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
Sponsor:
Tibotec Pharmaceuticals, Ireland
Organization:
Study Overview
Official Title:
A Phase II, Randomized, Active Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-na�ve and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use.
Status:
COMPLETED
Status Verified Date:
2010-10
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:
The purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) called TMC125.
Detailed Description:
Patients who have previously received a first HIV NNRTI containing regimen or who have received an NNRTI containing treatment for prevention of mother to child transmission (MTCT), and who have never used a protease inhibitor (PI) may be eligible to participate. TMC125 (at 800 mg b.i.d. of the old formulation and after the formulation switch, 200 mg b.i.d. of the new formulation) will be studied versus an active control (investigator selected PI). All patients will receive an underlying therapy containing 2 investigator selected NRTIs. 300 patients will be enrolled in Argentina, Brazil, Mexico, Peru, Chile, Costa Rica, Russia, South-Africa, Spain, Thailand, UK, USA, Thailand, India and Malaysia. The duration of the study is 48 weeks with an optional extension for patients in the TMC125 treatment group until virologic failure or commercial availability of the drug. TMC125 at 800mg twice daily of the old formulation; after the formulation switch, TMC125 at 200mg twice daily of the new formulation. The initial duration is 48 weeks with an optional extension for patients in the TMC125 treatment group until virologic failure or commercially availability.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: