Infection, Human Immunodeficiency VirusPhase 1/2NCT07711223
Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)
A Phase 1/2 study testing ACC017+FTC/TAF and DTG+FTC/TAF in people with Infection, Human Immunodeficiency Virus, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- ACC017+FTC/TAF and DTG+FTC/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2025to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
- 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);
- 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);
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- 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;
- 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);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital Capital Medical University, Beijing, China
Beijing
Zhang F Jie, M.D., Ph.D., 010-84322581, treatment@chinaaids.cn
Cai W Ping, M.D., Ph.D., 020-83822586, gz8hcwp@126.com
About this study
Official title: 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).
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- ACC017+FTC/TAF, DTG+FTC/TAF
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACC017+FTC/TAFDrug
ACC017+Emtricitabine/Tenofovir Alafenamide
DTG+FTC/TAFDrug
Dolutegravir+Emtricitabine/Tenofovir Alafenamide
| Study group | Role | What they receive |
|---|---|---|
| ACC017/FTC/TAF | Experimental | stage 1:Participants receive ACC017 tablets plus emtricitabine/tenofovir alafenamide (FTC/TAF) tablets. Receives: Drug: ACC017+FTC/TAF |
| DTG/FTC/TAF | Active comparator | stage1: Participants receive dolutegravir sodium tablets plus emtricitabine/tenofovir alafenamide (FTC/TAF) tablets. Receives: Drug: DTG+FTC/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 48
Secondary outcomes (18)
Percentage of participants with HIV RNA < LLOQ at Week 48;
Measured: week 48
Percentage of participants with HIV RNA <200 copies/mL at Week 48;
Measured: week 48
Percentage of participants with HIV RNA <50 copies/mL at Week 24;
Measured: week 24
Percentage of participants with HIV RNA < LLOQ at Week 24;
Measured: week 24
Absolute change from baseline in log10-transformed HIV RNA at Week 4;
Measured: week 4
Absolute change from baseline in log10-transformed HIV RNA at Week 8;
Measured: week 8
Absolute change from baseline in log10-transformed HIV RNA at Week 12;
Measured: week 12
Percentage of participants with HIV RNA <50 copies/mL at Week 96 (final analysis);
Measured: week 96
Percentage of participants with HIV RNA < LLOQ at Week 96.
Measured: week 96
Absolute change from baseline in CD4+ cell count at Week 48 (cells/μL);
Measured: week 48
Percentage of participants with an increase from baseline in CD4+ cell count of ≥100 cells/μL or ≥30% at Week 48;
Measured: week 48
Absolute change from baseline in CD4+ cell count at Week 96 (cells/μL).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant QT Interval Prolongation on 12-Lead ECG
Measured: 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.
Measured: 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.
Measured: week 1 - week 48; week 1 - week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start7 Nov 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang F Jie, M.D., Ph.D., Principal investigator, Beijing Ditan HospitalCai W Ping, M.D., Ph.D., Principal investigator, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711223
- Sponsor's protocol ID
- ADYY-ACC017-301
- Status last verified
- Oct 2025
- First submitted
- 7 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07711223
- Acronym / sponsor ID
- ADYY-ACC017-301
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACC017/FTC/TAF | Experimental | Drug: ACC017+FTC/TAFstage 1:Participants receive ACC017 tablets plus emtricitabine/tenofovir alafenamide (FTC/TAF) tablets. |
| DTG/FTC/TAF | Active comparator | Drug: DTG+FTC/TAFstage1: Participants receive dolutegravir sodium tablets plus emtricitabine/tenofovir alafenamide (FTC/TAF) tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACC017+FTC/TAFACC017+Emtricitabine/Tenofovir Alafenamide | Drug | ACC017/FTC/TAF |
| DTG+FTC/TAFDolutegravir+Emtricitabine/Tenofovir Alafenamide | Drug | DTG/FTC/TAF |
Primary outcome
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).
Time frame: week 48
18 secondary outcomes
Percentage of participants with HIV RNA < LLOQ at Week 48;
Time frame: week 48
Percentage of participants with HIV RNA <200 copies/mL at Week 48;
Time frame: week 48
Percentage of participants with HIV RNA <50 copies/mL at Week 24;
Time frame: week 24
Percentage of participants with HIV RNA < LLOQ at Week 24;
Time frame: week 24
Absolute change from baseline in log10-transformed HIV RNA at Week 4;
Time frame: week 4
Absolute change from baseline in log10-transformed HIV RNA at Week 8;
Time frame: week 8
Absolute change from baseline in log10-transformed HIV RNA at Week 12;
Time frame: week 12
Percentage of participants with HIV RNA <50 copies/mL at Week 96 (final analysis);
Time frame: week 96
Percentage of participants with HIV RNA < LLOQ at Week 96.
Time frame: week 96
Absolute change from baseline in CD4+ cell count at Week 48 (cells/μL);
Time frame: week 48
Percentage of participants with an increase from baseline in CD4+ cell count of ≥100 cells/μL or ≥30% at Week 48;
Time frame: week 48
Absolute change from baseline in CD4+ cell count at Week 96 (cells/μL).
Time frame: week 96
TEAEs (including ADRs, grade ≥3 AEs/ADRs, SAEs/SADRs, AEs/ADRs leading to treatment discontinuation/early trial withdrawal)
Time frame: week 1 - week 48; week 1 - week 96
changes in vital signs
Time frame: week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant Abnormal Physical Examination Findings
Time frame: week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant QT Interval Prolongation on 12-Lead ECG
Time frame: week 1 - week 48; week 1 - week 96
Number of Participants with Clinically Significant Laboratory Test Abnormalities
Time frame: week 1 - week 48; week 1 - week 96
Number of Participants with Changes in Concomitant Medications
Time frame: week 1 - week 48; week 1 - week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhang F Jie, M.D., Ph.D. principal investigator
Beijing Ditan Hospital
Cai W Ping, M.D., Ph.D. principal investigator
Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACC017+FTC/TAF and DTG+FTC/TAF in people with Infection, Human Immunodeficiency Virus, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qin Hong (+862583193135, qinh@aidea.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.