Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)

Ki vehet részt

• 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

Ki nem vehet részt

• 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
• Use of pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP) within 1 month before screening, or prior use of long-acting PrEP drugs (e.g., cabotegravir or lenacapavir, etc.)
• Within 30 days before screening, at screening, or planned use during the trial, systemic immunomodulators, cytotoxic drugs, etc. (see Appendix 7), and unwilling or unable to discontinue use from the time of informed consent
• At screening, known history of allergy to the investigational product, structurally related drugs, or excipients; or history of allergic diseases requiring medication control before screening (e.g., asthma, urticaria, atopic dermatitis [eczema], etc.)
• Before screening, major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy); or at screening, judged by the investigator as likely to require elective major surgery during the trial
• Before or at screening, intolerance to venipuncture, history of needle or blood phobia, or blood donation (including component blood) or significant blood loss (≥400 mL) or transfusion within 3 months before screening, or plans to donate blood during the trial
• Participation in any interventional clinical trial (including drugs, vaccines, or devices) within 3 months before screening
• 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, 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
• At screening, HBsAg-positive with HBV DNA ≥2000 IU/mL (local center testing), HCV antibody-positive with HCV RNA > LLOQ (local center testing), or judged by the investigator to require anti-syphilis treatment (participants who have completed standardized anti-syphilis treatment for ≥7 days may be considered)
• Within 5 years before screening, history of malignancy (except carcinoma in situ of the cervix treated by conization, or surgically cured basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ [Bowen's disease] of the skin)
• Within 5 years before screening, history of alcohol, drug, or other substance abuse (non-medical excessive, inappropriate, or addictive use of alcohol, drugs, or other substances leading to social, psychological, or physiological impairment)
• At screening, judged by the investigator to have clinically significant laboratory abnormalities, including but not limited to: hemoglobin (Hb) <90 g/L, or ALT >5 × ULN, or ALT >3 × ULN with total bilirubin (TBIL) >1.5 × ULN, or creatinine clearance <30 mL/min (CKD-EPI equation)