Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT01384734
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose
Status:
COMPLETED
Status Verified Date:
2018-08
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 assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.
Detailed Description:
Masking: Double-blind for BMS-6630368 treatment groups until the Week 24 Primary Endpoint analysis, then open label. The reference groups is all open-label.
Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)
Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)
Arms: 5 (4 BMS-663068 treatment groups and 1 reference group)
Intervention Model: Parallel (with unblinding after the Week 24 primary endpoint analysis)
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AI438-011 | OTHER | Bristol-Myers Squibb | View |