A Multicenter, Randomized, Double-Blind, Double-Dummy, Dolutegravir Sodium Tablets Controlled, Phase III Study to Evaluate the Efficacy and Safety of ACC017 Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)
This study employs a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group, non-inferiority design. The trial will be conducted in treatment-naïve adult patients with HIV-1, using Dolutegravir Sodium Tablets as the control, to demonstrate the efficacy and safety of the core investigational drug ACC017 combined with FTC/TAF Tablets (II) compared to Dolutegravir Sodium combined with FTC/TAF Tablets (II) in treating treatment-naïve adult HIV-1 patients. After initial screening eligibility is confirmed, participants will return to the clinic on Day 1 (D1) for re-evaluation of eligibility and completion of required examinations. Eligible participants will be randomized in a 1:1 ratio to receive either ACC017 Tablets (40 mg, once daily \[QD\]) or Dolutegravir Sodium Tablets (50 mg, QD). Both treatment groups will also receive FTC/TAF Tablets (II) and will undergo 48 weeks of continuous double-blind treatment. Subsequently, all study participants will transition to open-label treatment with ACC017 combined with FTC/TAF Tablets (III) for an additional 48 weeks (during which the dummy medication will no longer be administered).
⁃ A participant will be excluded from the trial if they meet any one or more of the following criteria:
• Voluntarily sign the written informed consent form, demonstrate the ability to understand and comply with the requirements of the study protocol;
• Age ≥18 years (inclusive) at the time of providing informed consent, both male and female participants are eligible;
• Diagnosed with HIV infection prior to informed consent, and have an HIV RNA viral load ≥500 copies/mL (tested at the local center) at screening;
• Have not received any ART since initial HIV diagnosis, and agree not to initiate any ART from the time of informed consent until randomization.