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

Condition(s) studied

Investigational drug(s) / intervention(s)

B/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.

TDF+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).

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

Study 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

Primary outcome measure(s)

• Rate of participants with virologic suppression — At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
  Virologic suppression is defined as a plasma viral load (HIV RNA) of less than 50 copies/mL.
• Change of CD4 count — At 12 weeks, 24 weeks, and 48 weeks from the initiation of ART.
  The percentage change in CD4+ T cell count from baseline after initiating ART, stratified by patients with lower versus higher baseline CD4+ levels.
• Rate of immune reconstitution in late presenters — At 48 weeks from the initiation of ART.
  Immune reconstitution is defined as an immunological response in HIV late presenters, characterized by a CD4+ T cell count increase of at least 20% from baseline or reaching at least 350 cells/μL at 48 weeks, accompanied by an undetectable viral load.

Trial sites (1)

More Affiliated Hospital of Nantong University trials in China

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