Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630286
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Study to Compare an Oral Weekly IslatravirLenacapavir Regimen With BictegravirEmtricitabineTenofovir Alafenamide in Virologically Suppressed People With HIV-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Active-controlled Study to Evaluate a Switch to an Oral Weekly IslatravirLenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on BictegravirEmtricitabineTenofovir Alafenamide BFTAF
Status:
NOT_YET_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:
ISLEND-1
Brief Summary:
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravirlenacapavir ISLLEN regimen versus continuing standard treatment of bictegraviremtricitabinetenofovir alafenamide BFTAF in people with human immunodeficiency virus PWH who are virologically suppressed HIV-1 RNA levels 50 copiesmL on BFTAF for 6 months prior to screening
The primary objective is to evaluate the efficacy of switching to oral weekly ISLLEN tablet regimen versus continuing BFTAF in virologically suppressed PWH at Week 48
The primary objective is to evaluate the efficacy of switching to oral weekly ISLLEN tablet regimen versus continuing BFTAF in virologically suppressed 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