NCT04296695

Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection

The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	B/F/TAF	randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
DRUG	TDF/3TC/EFV	TDF/3TC/EFV

Timeline

• Start date: 2021-07-14
• Primary completion: 2022-12-13
• Completion: 2023-12-31
• First posted: 2020-03-05
• Last updated: 2023-02-08

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study