Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified May 2019 by Peking Union Medical College Hospital

Sponsor
Peking Union Medical College Hospital


Information provided by (Responsible Party)
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier
NCT04296695

First received: March 3, 2020
Last updated: April 27, 2020
Last Verified: May 2019
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV-1-infection

Drug : B/F/TAF
Drug : TDF/3TC/EFV
Phase 4

Study Type: Interventional
Study Design: 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 China
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures

  • Proportion of participants with HIV-1 RNA [ Time Frame: Weeks 12 ]
  • The Change in CD4 T cell count from baseline [ Time Frame: Weeks 12, 24 and 48 ]

Estimated Enrollment: 250
Anticipated Study Start Date: July 1, 2020
Estimated Study Completion Date: October 1, 2021
Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Active Comparator: TDF/3TC/EFV
300mg/300mg/400mg
Drug: TDF/3TC/EFV

TDF/3TC/EFV

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.

Eligibility

Eligibility

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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04296695

Contacts

Contact:   Wei Lyu +8613501385800 lvweipumch@163.com
Contact:   Qing Zhang +13207572893 zhangqingpumch@163.com

Locations

China
The Guangxi Zhuang Autonomous Region Longtan Hospital
Liuzhou, Guangxi, China, 545005
Contact: RUICHAO LU    +8613607825966    ruichaolu@163.com
Principal Investigator: RUICHAO LU
Guiyang Public Health Clinic Center
Guiyang, Guizhou, China, 550004
The Second Hospital of Nanjing
Najing, Jiangsu, China, 210003
Contact: HONGXIA WEI    +8613851507368    wghongxia@sina.com
Principal Investigator: HONGXIA WEI
Xi'an Number Eight Hospital
Xi'an, Shanxi, China, 710061
Contact: JUAN JIN    +8613484906957    13484906957@163.com
Principal Investigator: JUAN JIN
Tianjin Second People's Hospital
Tianjin, China, 300192
Contact: PING MA    +8615922124490    mapingtianjin@163.com
Principal Investigator: PING MA

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator: Wei Lyu Department of Infectious Diseases, PekingUMCH
More Information

More Information


Responsible Party: Peking Union Medical College Hospital  
ClinicalTrials.gov Identifier: NCT04296695   History of Changes  
Other Study ID Numbers: Gilead ISR-CN-18-10596  
Study First Received: March 3, 2020  
Last Updated: April 27, 2020  

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:
Infection
Communicable Diseases
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.