Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT04296695
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2020-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
Detailed Description:
HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.
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?:
True
Is an FDA AA801 Violation?: