Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255099
Status:
COMPLETED
Last Update Posted:
2011-06-15
First Post:
2005-11-15
Brief Title:
TMC125-C216 A Phase III Study to Investigate the Efficacy Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen Including TMC114Ritonavir and an Investigator-selected Optimized Background in HIV-1 Infected Patients With Limited to no Treatment Options
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Phase III Randomized Double-blinded Placebo-controlled Trial to Investigate the Efficacy Tolerability and Safety of TMC125 as Part of an ART Regimen Including TMC114RTV and an Investigator-selected OBR in HIV-1 Infected Patients With Limited Treatment to no Treatment Options
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
The purpose of this study is research with the goal of evaluating the effect of TMC125 a non-nucleoside reverse transcriptase inhibitor on slowing down the growth of the HIV virus The study will also investigate whether this new medication is well tolerated and to further confirm that the medication is safe to be used
Detailed Description:
This is a Phase III randomized double-blind placebo-controlled trial to evaluate the long-term efficacy tolerability and safety of TMC125 as part of an antiretroviral therapy ART regimen containing TMC114ritonavir RTV and an investigator-selected optimized background OBR in treatment-experienced HIV-1 infected patients TMC125 is a non-nucleoside reverse transcriptase inhibitor NNRTI TMC114 is a protease inhibitor PI In this trial TMC114 will be given with a low dose of ritonavir RTV a protease inhibitor commonly used with other full dose protease inhibitors to improve activity Additional assessments to be evaluated in this trial include changes in the HIV-1 genotype drug susceptibility and the population pharmacokinetics of TMC125 A pharmacokinetic substudy will be performed at selected sites Health-related quality of life will be assessed for patients receiving an antiretroviral therapy containing either TMC125 or placebo Safety and tolerability will be documented throughout the trial Six hundred HIV-1 infected patients on a stable but virologically failing regimen will be included in the trial Patients should have at least 1 documented non-nucleoside reverse transcriptase inhibitor NNRTI resistance-associated mutation either at screening or from historical genotype reports an HIV-1 plasma viral load 5000 RNA copiesmL at screening and at least 3 documented primary protease inhibitor PI mutations Patients will be randomized in a 11 ratio to either TMC125 200 mg twice daily or to matching placebo both in combination with TMC114RTV 600100 mg twice daily and an investigator selected OBR of at least 2 antiretrovirals ARVs consisting of nucleoside reverse transcriptase inhibitors NRTIs with or without enfuvirtide The trial will involve a screening period of up to 6 weeks a 48-week treatment period and a 4 week follow-up period Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets twice daily administered as 2 tablets twice daily with food in combination with 600 mg oral doses of TMC114 tablets and 100 mg oral doses of ritonavir administered as 2 tablets of TMC114 and 1 capsule of ritonavir twice daily with food The treatment period is 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TMC125-C216 | None | None | None |