Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128830
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2005-08-08
Brief Title:
A Study With TMC125 in Human Immunodeficiency Virus HIV Type 1 Infected Patients Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
An Open-Label Trial With TMC125 in HIV-1 Infected Subjects Who Were Randomized to a TMC125 Treatment Arm in a Sponsor-Selected TMC125 Trial and Were Treated for at Least 48 Weeks
Status:
COMPLETED
Status Verified Date:
2013-06
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 to evaluate the long-term safety and tolerability of etravirine administered as part of an individually optimized antiretroviral therapy ART in human immunodeficiency virus Type 1 HIV-1 infected participants
Detailed Description:
This is a Phase II open-label all people know the identity of the intervention roll-over study participants may go ahead and participate in another clinical study Participants who were randomized study medication is assigned by chance to a etravirine ETR treatment arm in Phase II TMC125 feeder studies TMC125-C203 TMC125-C209 TMC125-C223 and TMC125-C211 were treated for at least 48 weeks with etravirine and who will derive continued benefit from etravirine therapy as judged by the investigator will be enrolled in this study The final visit of the sponsor-selected Phase II ETR study will be the first baseline visit of this study Approximately 300 participants will be enrolled in this study who will receive 800 mg twice daily of etravirine formulation TF035 until the formulation 200 mg twice daily formulation F060 is available Once this formulation becomes available all the participants will be switched to receive F060 which will be given in combination with an investigator-selected optimized underlying therapy nucleotide reverse transcriptase NRTIs andor allowed protease inhibitors andor enfuvirtide Participants will continue to receive ETR until they are no longer benefitted or this medication becomes commercially available Safety evaluations will include assessment of adverse events clinical laboratory tests electrocardiogram vital signs and physical examination
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-C229 | OTHER | Tibotec Pharmaceuticals Ireland | None |