RecruitingNCT06619288

Good-first: B/F/TAF As First-line ART

Good-first: a Multicohort Study of B/F/TAF As First-line ART in a Public Hospital in Eastern China


Sponsor

Affiliated Hospital of Nantong University

Enrollment

630 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This is a multicohort study conducted at Affiliated Hospital of Nantong University, and Nantong Third Peoples Hospital (Designated Hospital for HIV/AIDS Treatment of Nantong City), China. The study would involve 630 patients initiating HIV treatment, divided into six cohorts. The enrollment period for the prospective cohort is from July 2024 to June 2025, while the enrollment period for the retrospective cohort is from January 2020 to June 2023.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a specific HIV treatment — B/F/TAF (bictegravir/emtricitabine/tenofovir alafenamide, brand name Biktarvy) — as a first-line antiretroviral therapy (ART) for people newly diagnosed with HIV. Researchers are comparing it to older regimens (TDF+3TC+EFV or DTG/3TC) to see how well it works and how safe it is in a real-world setting. **You may be eligible if...** - You are 18 or older and have been diagnosed with HIV/AIDS - You have never taken HIV medications before (ART-naive) - You were diagnosed between July 2024 and June 2025 (prospective enrollment) or January 2020 and June 2023 (retrospective review) - You are eligible to start B/F/TAF or were previously treated with TDF+3TC+EFV or DTG/3TC - You are willing to follow study visits or have complete electronic health records available **You may NOT be eligible if...** - You have severe kidney problems (creatinine clearance under 50 mL/min) - You have hepatitis B co-infection or severe liver disease - You have active tuberculosis (TB) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGB/F/TAF

Take one tablet per dose, once daily. Each tablet contains bictegravir (BIC) 50 mg, emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 25 mg.

DRUGTDF+3TC+EFV

Take five tablets per dose, once daily. Each dose contains one tablet of tenofovir (TDF) 300 mg, one tablet of lamivudine (3TC) 300 mg, and three tablets of efavirenz (EFV) 200 mg (totaling 600 mg).

DRUGDTG/3TC

Take one tablet per dose, once daily. Each tablet contains dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg.


Locations(1)

Nantong Third Peoples Hospital

Nantong, Jiangsu, China

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NCT06619288


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