Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333808
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-20
Brief Title:
Study to Compare BictegravirLenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of BictegravirLenacapavir Versus Biktarvy BictegravirEmtricitabineTenofovir Alafenamide in Virologically Suppressed People With HIV-1
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ARTISTRY-2
Brief Summary:
The goal of this clinical study is to learn more about the effects of switching to the study drugs bictegravir BIClenacapavir LEN fixed-dose combination FDC versus current therapy bictegraviremtricitabinetenofovir alafenamide BFTAF FDC in people living with HIV-1 PWH
The primary objective of this study is to learn how effective it is to switch to BICLEN FDC tablets versus continuing on BFTAF FDC tablets in virologically suppressed PWH
The primary objective of this study is to learn how effective it is to switch to BICLEN FDC tablets versus continuing on BFTAF FDC tablets in virologically suppressed PWH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2023-510022-33 | OTHER | European Medicines Agency | None |