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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04296695
Collaborator
Gilead Sciences (Industry)
250
Enrollment
3
Locations
2
Arms
29.6
Anticipated Duration (Months)
83.3
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in ChinaNon-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China
Masking:
None (Open Label)
Masking Description:
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Actual Study Start Date :
Jul 14, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: B/F/TAF

50mg/600mg/300mg

Drug: B/F/TAF
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
Other Names:
  • Biktarvy

    		•
    Active Comparator: TDF/3TC/EFV

    300mg/300mg/400mg

    Drug: TDF/3TC/EFV
    TDF/3TC/EFV
    Other Names:
  • Tenofovir /Ravmidine /Efavirenz

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with HIV-1 RNA [base line,Weeks 12,24 and 48]

      Proportion of participants with HIV-1 RNA

    2. The Change in CD4 T cell count from baseline [base line,Weeks 12, 24 and 48]

      The Change in CD4 T cell count from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. A new AIDS-defining condition diagnosed within the 30 days prior to screening

    2. Participants experiencing severe organ lesion.

    3. Positive serum pregnancy test or planned to be pregnant.

    4. Females who are breastfeeding

    5. With carcinoma

    6. Concomitant medication of immunosuppression or chemoradiotherapy

    7. Participation in any other interventional clinical trial

    8. 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.

    9. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Guangxi Zhuang Autonomous Region Longtan Hospital Liuzhou Guangxi China 545005
    2 The Second Hospital of Nanjing Najing Jiangsu China 210003
    3 Tianjin Second People's Hospital Tianjin China 300192

    Sponsors and Collaborators

    • Peking Union Medical College Hospital
    • Gilead Sciences

    Investigators

    • Principal Investigator: Wei Lyu, Department of Infectious Diseases, PekingUMCH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT04296695
    Other Study ID Numbers:
    • Gilead ISR-CN-18-10596
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Peking Union Medical College Hospital
    Biktarvy
    HIV-1 infection
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    HIV Infections
    Tenofovir
    Efavirenz

    Study Results

    No Results Posted as of Apr 4, 2022