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

Phase 4

Active, not recruiting

• Conditions: HIV-1-infection
• Interventions: Drug: B/F/TAF; Drug: TDF/3TC/EFV

• Registration Number: NCT04296695
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-05
• Study Start: 2021-07-14
• Primary Completion: 2022-12-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B/F/TAF	B/F/TAF	50mg/600mg/300mg
TDF/3TC/EFV	TDF/3TC/EFV	300mg/300mg/400mg

Primary Outcome Measures

Name	Time	Method
Proportion of participants with HIV-1 RNA	base line,Weeks 12,24 and 48	Proportion of participants with HIV-1 RNA
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

Trial Locations

Locations (3)

The Second Hospital of Nanjing; 🇨🇳 Najing, Jiangsu, China

Tianjin Second People's Hospital; 🇨🇳 Tianjin, China

The Guangxi Zhuang Autonomous Region Longtan Hospital; 🇨🇳 Liuzhou, Guangxi, China