Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359021
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2006-07-28
Brief Title:
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial TMC125-C206 or TMC125-C216
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
An Open-label Trial With TMC125 as Part of an ART Including TMC114Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial TMC125-C206 or TMC125-C216
Status:
COMPLETED
Status Verified Date:
2014-05
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 trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial TMC125-C206 or TMC125 C216 and have met the definition of virologic failure at Week 24 or later in these trials
Detailed Description:
This is a Phase III open-label roll-over trial to evaluate the long term tolerability safety antiviral and immunological effect of TMC125 as part of an individually optimized antiretroviral therapy including TMC114rtv in HIV-1 infected patients who participated in one of the DUET TMC125-C206 or TMC125-C216 trials Also the change in HIV-1 resistance over time will be evaluated This trial offers patients meeting the definition of virologic failure at Week 24 or beyond the option to roll-over to an open-label trial where they will receive TMC125 and TMC114rtv Three hundred patients are estimated to enroll into this trial The withdrawal visit of the DUET trial will be the first visit of this trial From this visit onward all patients will receive 200 mg twice daily TMC125 and 600100 mg twice daily TMC114rtv until both TMC114 and TMC125 are commercially available or the therapy is no longer of clinical benefit to the patient Patients will receive an antiretroviral therapy consisting of TMC125 as the only non-nucleoside reverse transcriptase inhibitor NNRTI TMC114rtv as the only protease inhibitor PI and an optimized background which will be selected by the investigator according to the local standard of care the patients experience with previous therapies and most recent resistance testing The most recent HIV-1 genotype-analysis system report results from the DUET trial will be made available TMC125 will be dosed at 200 mg twice daily administered orally as 2 tablets twice daily with foodTMC114rtv will be dosed at 600100 mg twice daily administered orally as 2 tablets TMC114 and 1 capsule ritonavir twice daily with foodThe optimized background will comprise of at least 1 approved ARV drug 1 or more NRTIs with or without ENF Administration will continue until both TMC114 and TMC125 are commercially available or therapy is no longer of clinical benefit to the patient
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 | OTHER | Tibotec Pharmaceuticals | None |
| TMC125-C217 | OTHER | None | None |
| TMC125-C206 | OTHER | None | None |