Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV -1 Infection
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in ChinaMasking: None (Open Label)Masking Description: randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFVPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 antir...
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.
Tracking Information
- NCT #
- NCT04296695
- Collaborators
- Gilead Sciences
- Investigators
- Principal Investigator: Wei Lyu Department of Infectious Diseases, PekingUMCH
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