Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110305
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2005-05-05
Brief Title:
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients Who Are Not Treated With Antiretroviral Medicines
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Phase IIb Randomized Partially Blinded Dose-Finding Trial of TMC278 in Antiretroviral-Naive HIV-1 Infected 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 purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278
Detailed Description:
This is a randomized the study medication is assigned by chance active controlled participants are assigned to either a recognized effective treatment or the study medication study This study consists of 3 phases screening phase 4 weeks treatment phase 96 weeks and follow up phase 4 weeks In the treatment phase participants will be randomly assigned to 1 of the 4 treatment groups 1 TMC278 25 mg 2 TMC278 75 mg 3 TMC278 150 mg or 4 efavirnez control group along with investigator selected 2 non-nucleoside reverse transcriptase inhibitor NRTIs until Week 96 TMC278 will be assigned by double-blinded fashion participant and investigator are not aware of the TMC278 dose what participants will receive and efavirnez will be assigned by open-label fashion all people know what treatment participants will receive After Week 96 3 optional open-label all people know the identity of the intervention extension periods will be conducted to collect long term safety and effectiveness data of TMC278 3 optional extension periods are first optional extension period all participants will receive TMC278 75 mg 2 NRTIs from Week 96 to Week144 second optional extension period all participants will receive TMC278 25 mg 2 NRTIs from Week 144 to Week 240 and third optional extension period all participants will receive TMC278 25 mg 2 NRTIs from Week 240 until TMC278 is commercially available Participants on efavirenz group will have the option to continue on efavirenz 2 NRTIs until the total treatment duration of 240 weeks Safety evaluations will include assessment of adverse events clinical laboratory tests electrocardiogram physical examination and vital signs which will be monitored throughout the study The maximum duration of the study will be 104 152 or 248 weeks plus the optional third extension period
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 |
|---|---|---|---|
| TMC278-C204 | OTHER | None | None |
| R278474-C204 | OTHER | Tibotec Pharmaceuticals Ireland | None |