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).
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.
Participants judged by the investigator as having poor treatment compliance or protocol adherence, or any other condition making them unsuitable for the study, or when participation may not best protect the participant's health interests;
At screening, female participants who are pregnant, breastfeeding, or have a positive blood pregnancy test; or from 1 month before screening until 3 months after the last dose of the investigational product, participants of childbearing potential (WOCBP) or male participants with plans for procreation (including egg or sperm donation), or unwilling to use effective contraception (including one or more non-pharmacological methods, or absence of heterosexual activity in daily life) or safety measures;
At screening, judged by the investigator to be in the acute phase of HIV-1 infection, or with opportunistic infections or other clinically significant AIDS-defining conditions within 3 months before screening;
At screening, judged by the investigator to have poorly controlled clinically significant diseases (including cardiovascular, respiratory, digestive, endocrine-metabolic, neuropsychiatric, hematological, and immune systems, etc.), including but not limited to: poorly controlled hypertension despite active treatment (resting SBP ≥160 mmHg or DBP ≥100 mmHg upon retest), NYHA Class III or IV cardiac function, GOLD Grade 3-4 COPD, severe liver impairment (Child-Pugh Class C), etc.;
Parallel
ACC017+FTC/TAF
DrugACC017+Emtricitabine/Tenofovir Alafenamide
DTG+FTC/TAF
DrugDolutegravir+Emtricitabine/Tenofovir Alafenamide
At 48 weeks of treatment, the percentage of participants with HIV RNA load <50 copies/mL (analyzed using the US FDA Snapshot Approach) (primary analysis).
Percentage of participants with HIV RNA < LLOQ at Week 48;
Percentage of participants with HIV RNA <200 copies/mL at Week 48;
Percentage of participants with HIV RNA <50 copies/mL at Week 24;
Percentage of participants with HIV RNA < LLOQ at Week 24;
Evaluation of integrase strand transfer inhibitor resistance-associated mutations(INSTI RAM) change from baseline through Week 48;
Evaluation of NRTI RAM change from baseline through Week 48;
Plasma Trough Concentration (Ctrough) of ACC017
Plasma trough concentration (Ctrough) of ACC017, defined as the pre-dose concentration at steady-state, measured at Week 4, Week 12, Week 24, and Week 48.
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