Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081588
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2004-04-15
Brief Title:
An Open Label Trial of TMC114RTV in HIV-1 Infected Treatment-experienced Subjects
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
An Open Label Trial of TMC114RTV in HIV-1 Infected Treatment-experienced Subjects
Status:
COMPLETED
Status Verified Date:
2014-06
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 primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114RTV over time The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time
Detailed Description:
The study will continue for 144 weeks after study medication has begun For patients failing treatment they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria It is estimated that approximately 150 patients may meet these criteria Major inclusion and exclusion criteria are listed below For new patients they must have been on prior antiretroviral therapy including more than one nucleoside reverse transcriptase inhibitor NRTI one non-nucleoside reverse transcriptase inhibitor NNRTI and a protease inhibitor PI At least one primary PI mutation must be present at screening Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study The recruitment of new patients for the TMC114-C215 trial has been fully enrolled The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study Two 300mg100mg DarunavirRitonavir tablets twice daily for 144 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 |
|---|---|---|---|
| TMC114-C215 | None | None | None |