Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04871113
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-04-28
Brief Title:
A Study to Evaluate the Antiviral Effect Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus HIV-1 Infected Adults
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Phase 2a Multicentre Randomized Open-Label Two-Part Adaptive Design Study to Evaluate the Antiviral Effect Safety and Tolerability of GSK3810109A an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naïve HIV-1-Infected Adults
Status:
COMPLETED
Status Verified Date:
2024-09
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:
This study is to evaluate antiviral activity efficacy safety tolerability pharmacokinetics PK and pharmacodynamics PD of GSK3810109A in HIV-1 infected treatment naive adults Participants will receive a single dose of GSK3810109A administered either intravenously IV or subcutaneously SC The study includes a screening phase a randomized monotherapy phase and a standard of care follow-up phase
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