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

Study Overview
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Brief Summary
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The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection

Detailed Description
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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.

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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Drug: B/F/TAF
* Drug: TDF/3TC/EFV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Ability to understand and sign a written informed consent form 2.18 years old or older 3.Confirmed HIV-antibody positive through Western Blot testing without any previous ART 4.CD4 < 200/mm3, VL >1000 copies/ml 5.Estimated glomerular filtration rate (GFR) ≥ 50 mL/min (calculated by CKD-EPI) 6.Clinical status relatively stable 7.Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually from screening throughout the duration of study treatment and for 30 days following the last dose of study drug. Exclusion Criteria: A new AIDS-defining condition diagnosed within the 30 days prior to screening Participants experiencing severe organ lesion. Positive serum pregnancy test or planned to be pregnant. Females who are breastfeeding With carcinoma Concomitant medication of immunosuppression or chemoradiotherapy Participation in any other interventional clinical trial Screening stage find: Hb < 9g/dL, WBC < 3000/ul. neutrophilic granulocyte< 1500/ul, PLT< 75000/ul. Scr > 1.5 ULN,Hepatic transaminases (AST and ALT) and ALP > 3 × ULN,total bilirubin ≤ 2 x ULN. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B/F/TAF<br>50mg/600mg/300mg | Drug: B/F/TAF<br>* randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV<br>* Other names: Biktarvy;|
| Active Comparator: TDF/3TC/EFV<br>300mg/300mg/400mg | Drug: TDF/3TC/EFV<br>* TDF/3TC/EFV<br>* Other names: Tenofovir /Ravmidine /Efavirenz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with HIV-1 RNA | Proportion of participants with HIV-1 RNA | base line,Weeks 12,24 and 48 | 
| The Change in CD4 T cell count from baseline | The Change in CD4 T cell count from baseline | base line,Weeks 12, 24 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biktarvy, HIV-1 infection