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

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).

Study Overview

• Status: Recruiting
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: ACC017+FTC/TAF; Drug: DTG+FTC/TAF

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qin Hong; Phone Number: +862583193135; Email: qinh@aidea.com.cn
• Study Contact Backup: Name: Zhou F Mei; Phone Number: 18783835123; Email: zhoufamei@aidea.com.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Ditan Hospital Capital Medical University, Beijing, China
    • Contact: Zhang F Jie, M.D., Ph.D.; Phone Number: 010-84322581; Email: treatment@chinaaids.cn
    • Contact: Cai W Ping, M.D., Ph.D.; Phone Number: 020-83822586; Email: gz8hcwp@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A participant will be excluded from the trial if they meet any one or more of the following criteria:

1. Voluntarily sign the written informed consent form, demonstrate the ability to understand and comply with the requirements of the study protocol;
2. Age ≥18 years (inclusive) at the time of providing informed consent, both male and female participants are eligible;
3. 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;
4. Have not received any ART since initial HIV diagnosis, and agree not to initiate any ART from the time of informed consent until randomization.

Exclusion Criteria:

1. 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;
2. 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;
3. 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;
4. 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.;
5. 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);
6. 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);
7. 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.);
8. 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;
9. 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.);
10. 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;
11. 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);
12. 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);
13. 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;
14. Participation in any interventional clinical trial (including drugs, vaccines, or devices) within 3 months before screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACC017/FTC/TAF; stage 1:Participants receive ACC017 tablets plus emtricitabine/tenofovir alafenamide (FTC/TAF) tablets.	Drug: ACC017+FTC/TAF; ACC017+Emtricitabine/Tenofovir Alafenamide
Active Comparator: DTG/FTC/TAF; stage1: Participants receive dolutegravir sodium tablets plus emtricitabine/tenofovir alafenamide (FTC/TAF) tablets.	Drug: DTG+FTC/TAF; Dolutegravir+Emtricitabine/Tenofovir Alafenamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with HIV RNA < LLOQ at Week 48;		week 48
Percentage of participants with HIV RNA <200 copies/mL at Week 48;		week 48
Percentage of participants with HIV RNA <50 copies/mL at Week 24;		week 24
Percentage of participants with HIV RNA < LLOQ at Week 24;		week 24
Absolute change from baseline in log10-transformed HIV RNA at Week 4;		week 4
Absolute change from baseline in log10-transformed HIV RNA at Week 8;		week 8
Absolute change from baseline in log10-transformed HIV RNA at Week 12;		week 12
Percentage of participants with HIV RNA <50 copies/mL at Week 96 (final analysis);		week 96
Percentage of participants with HIV RNA < LLOQ at Week 96.		week 96
Absolute change from baseline in CD4+ cell count at Week 48 (cells/μL);		week 48
Percentage of participants with an increase from baseline in CD4+ cell count of ≥100 cells/μL or ≥30% at Week 48;		week 48
Absolute change from baseline in CD4+ cell count at Week 96 (cells/μL).		week 96
TEAEs (including ADRs, grade ≥3 AEs/ADRs, SAEs/SADRs, AEs/ADRs leading to treatment discontinuation/early trial withdrawal)	Number and percentage of participants with treatment-emergent adverse events (TEAEs), including those with adverse drug reactions (ADRs), grade ≥3 TEAEs, grade ≥3 ADRs, serious adverse events (SAEs), serious adverse drug reactions (SADRs), and TEAEs/ADRs leading to treatment discontinuation or early trial withdrawal, during the study period.	week 1 - week 48; week 1 - week 96
changes in vital signs	Number of participants with treatment-emergent clinically significant abnormalities in vital signs. Parameters assessed include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance is determined by the investigator according to protocol-specified criteria.	week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant Abnormal Physical Examination Findings	Number of participants with treatment-emergent, clinically significant new or worsened abnormalities on physical examination, as assessed by the investigator across major body systems.	week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant QT Interval Prolongation on 12-Lead ECG		week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant Laboratory Test Abnormalities	Number of participants with treatment-emergent clinically significant abnormalities in hematology and chemistry laboratory parameters. Individual parameters include hemoglobin, white blood cell count, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and serum creatinine. Clinical significance is determined by the investigator based on predefined criteria.	week 1 - week 48; week 1 - week 96
Number of Participants with Changes in Concomitant Medications	Number of participants with any new initiation, dose adjustment, or discontinuation of concomitant medications during the study period.	week 1 - week 48; week 1 - week 96

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of integrase strand transfer inhibitor resistance-associated mutations(INSTI RAM) change from baseline through Week 48;		week 0 - week 48
Evaluation of NRTI RAM change from baseline through Week 48;		week 0 - 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.	week 0 -week 48

Collaborators and Investigators

• Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Zhang F Jie, M.D., Ph.D., Beijing Ditan Hospital; Principal Investigator: Cai W Ping, M.D., Ph.D., Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Infections
• Other Study ID Numbers: ADYY-ACC017-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No