Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111280
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-05-18
Brief Title:
TMC125-C211 Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
HIV-1 Infected Subjects Who Were Randomized in Any Sponsor-selected TMC125 Trial to an Active Control Arm and Either Virologically Failed or Completed the Entire Treatment Period or to Placebo Arm and Were Treated for at Least 48 Weeks
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:
This is a Phase II open-label roll-over trial to evaluate the long term safety and tolerability of TMC125 administered as part of an individually optimized antiretroviral therapy in HIV 1 infected subjects In addition the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time and the evolution of HIV phenotype and genotype will be evaluated
Detailed Description:
The purpose of this Phase II open-label roll-over trial is to evaluate the long term safety and tolerability of TMC125 administered as part of an individually optimized antiretroviral therapy in HIV 1 infected subjects In addition the antiviral activity and immunological effect of TMC125 as part of an antiretroviral regimen over time and the evolution of HIV phenotype and genotype will be evaluated Subjects who were randomized to an active control arm of any sponsor-selected TMC125 trial and virologically failed or completed the entire treatment period or to placebo arm and were treated for at least 48 and who may derive benefit from TMC125 treatment as judged by the investigator can be enrolled Based on the currently selected studies a maximum of 170 subjects will be enrolled in the current trial A dose of 800mg bid of TMC125 formulation TF035 and after the formulation switch 200mg bid formulation F060 will be given in combination with an investigator-selected optimized underlying therapy starting at baseline and consisting of at least 2 drugs nucleoside reverse transcriptase inhibitors NRTIs andor allowed protease inhibitors PIs andor enfuvirtide T 20 for 48 weeks Tolerability and safety will be assessed throughout the trial The efficacy parameters will be determined at defined time points during the trial The trial will involve a screening visit preferable on the same day as the withdrawal visit of the sponsor-selected trial a baseline visit a treatment period of 48 weeks a final visit and a 4 week follow-up period TMC125 800 mg twice a day and after formulation switch at 200 mg twice a day
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