Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532656
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Study of BictegravirLenacapavir in Children and Adolescents With HIV-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 23 Open-Label Study to Evaluate the Pharmacokinetics Safety and Antiviral Activity of BictegravirLenacapavir in Children and Adolescents With HIV-1
Status:
RECRUITING
Status Verified Date:
2024-09
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 about the safety and tolerability of bictegravirlenacapavir BICLEN and to learn how the study drug interacts with the body in virologically suppressed VS children and adolescents with human immunodeficiency virus type 1 HIV-1 on a stable and complex antiretroviral ARV regimen The study will also assess the safe loading dose of LEN and pharmacokinetics PK of BICLEN
The primary objectives of this study are
To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BICLEN FDC in VS children and adolescents with HIV-1
To evaluate the safety and tolerability of BICLEN through Week 24 in VS children and adolescents with HIV-1
The primary objectives of this study are
To evaluate the steady-state PK of BIC and LEN and confirm the dose of the LEN loading dose and BICLEN FDC in VS children and adolescents with HIV-1
To evaluate the safety and tolerability of BICLEN through Week 24 in VS children and adolescents with HIV-1
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