Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613685
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Operationally Seamless Phase 23 Randomized Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to learn more about the experimental drugs GS-1720 an oral long-acting integrase strand transfer inhibitor INSTI and GS-4182 a prodrug of Lenacapavir LEN to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegraviremtricitabinetenofovir alafenamide BFTAF Biktarvy to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 HIV-1 infection in treatment-naive people with HIV-1 PWH
This study has two phases Phase 2 and Phase 3
The primary objectives of this study are
Phase 2 To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy BVY in treatment-naive PWH at Week 24
Phase 3 To evaluate the efficacy of oral weekly GS-1720GS-4182 fixed-dose combination FDC tablet regimen versus continuing BVY in treatment-naive PWH at Week 48
This study has two phases Phase 2 and Phase 3
The primary objectives of this study are
Phase 2 To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy BVY in treatment-naive PWH at Week 24
Phase 3 To evaluate the efficacy of oral weekly GS-1720GS-4182 fixed-dose combination FDC tablet regimen versus continuing BVY in treatment-naive PWH at Week 48
Detailed Description:
None
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