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

Primary Purpose

HIV-1-infection

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
B/F/TAF
TDF/3TC/EFV
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1-infection focused on measuring Biktarvy, HIV-1 infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Guangxi Zhuang Autonomous Region Longtan Hospital
  • The Second Hospital of Nanjing
  • Tianjin Second People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

B/F/TAF

TDF/3TC/EFV

Arm Description

50mg/600mg/300mg

300mg/300mg/400mg

Outcomes

Primary Outcome Measures

Proportion of participants with HIV-1 RNA
Proportion of participants with HIV-1 RNA
The Change in CD4 T cell count from baseline
The Change in CD4 T cell count from baseline

Secondary Outcome Measures

Full Information

First Posted
March 3, 2020
Last Updated
February 7, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04296695
Brief Title
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Official Title
The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
December 13, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Gilead Sciences

4. Oversight

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection
Keywords
Biktarvy, HIV-1 infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Masking Description
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B/F/TAF
Arm Type
Experimental
Arm Description
50mg/600mg/300mg
Arm Title
TDF/3TC/EFV
Arm Type
Active Comparator
Arm Description
300mg/300mg/400mg
Intervention Type
Drug
Intervention Name(s)
B/F/TAF
Other Intervention Name(s)
Biktarvy
Intervention Description
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
Intervention Type
Drug
Intervention Name(s)
TDF/3TC/EFV
Other Intervention Name(s)
Tenofovir /Ravmidine /Efavirenz
Intervention Description
TDF/3TC/EFV
Primary Outcome Measure Information:
Title
Proportion of participants with HIV-1 RNA
Description
Proportion of participants with HIV-1 RNA
Time Frame
base line,Weeks 12,24 and 48
Title
The Change in CD4 T cell count from baseline
Description
The Change in CD4 T cell count from baseline
Time Frame
base line,Weeks 12, 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Lyu
Organizational Affiliation
Department of Infectious Diseases, PekingUMCH
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Guangxi Zhuang Autonomous Region Longtan Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545005
Country
China
Facility Name
The Second Hospital of Nanjing
City
Najing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
Tianjin Second People's Hospital
City
Tianjin
ZIP/Postal Code
300192
Country
China

12. IPD Sharing Statement

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

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