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

Gilead ISR-CN-18-10596

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

2021-07-14

2022-12-13

2023-12-31

Active (not recruiting)

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-inferioty or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV'}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

2023-02-08