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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04296695
• Other study ID #: Gilead ISR-CN-18-10596
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 14, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 31, 2023
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1-infection
• Infections

Intervention

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

Locations

Country	Name	City	State
China	The Guangxi Zhuang Autonomous Region Longtan Hospital	Liuzhou	Guangxi
China	The Second Hospital of Nanjing	Najing	Jiangsu
China	Tianjin Second People's Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Gilead Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with HIV-1 RNA	Proportion of participants with HIV-1 RNA	base line,Weeks 12,24 and 48
Primary	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