Infection, Human Immunodeficiency VirusPhase 1/2NCT07711210

Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance Mutations

A Phase 1/2 study testing ACC017 in people with Infection, Human Immunodeficiency Virus, run by Jiangsu Aidea Pharmaceutical Group Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This trial is a randomized, double-blind, placebo-controlled clinical study conducted in treatment-experienced adults with NNRTI-resistant HIV-1, designed to preliminarily evaluate the efficacy, safety, and resistance profile of the core drug ACC017 in this population. 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteChina
Study dates: 21 Mar 2025to 30 Dec 2027
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

Participants must meet all of the following criteria to be eligible for this trial:
Voluntarily sign the informed consent form before screening and be able to comply with the protocol procedures or agreed requirements;
Age ≥18 years (inclusive) at the time of signing the informed consent, regardless of gender;
Diagnosed with HIV-1 infection before screening, having received the current first-line antiretroviral therapy (i.e., one NNRTI combined with two NRTIs) for at least 6 months (changes in treatment regimen due to tolerability issues or other adverse reactions are acceptable), with treatment interruption ≤4 weeks before screening (if applicable);
Before and at screening, no prior use of INSTI, PI, or other novel antiretroviral drugs (including but not limited to fusion inhibitors [FI] or capsid inhibitors [CAI]), including for pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP);
At least one HIV-1 RNA test result ≥400 copies/mL within 8 weeks before screening, and confirmed HIV-1 RNA ≥400 copies/mL at screening (with ≥7 days between the two tests); or at least one HIV-1 RNA test result ≥50 copies/mL to <400 copies/mL within 8 weeks before screening, and confirmed HIV-1 RNA ≥1000 copies/mL at screening (with ≥7 days between the two tests);

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Within 8 weeks before or at screening, documented NNRTI resistance mutations in the resistance test results (as interpreted by the Stanford HIVdb database, including "low-level resistance [L]," "intermediate resistance [I]," and "high-level resistance [H]") (if two test results exist, the most recent one shall prevail);
At screening, based on resistance test results, at least one fully active NRTI backbone drug is available for optimized background therapy in the trial (as interpreted by the Stanford HIVdb database, including "susceptible [S]" and "potential low-level resistance [P]");
Participants agree not to modify their antiretroviral treatment regimen-including but not limited to the composition, dosage, or frequency of regimen drugs-without the investigator's consent from the time of signing the informed consent until the end of the study.

Who cannot join

Participants will be excluded from this trial if they meet any of the following criteria:
The investigator judges that the participant has poor treatment compliance or protocol adherence, or any other condition that makes them unsuitable for participation, or that participation may not maximize the participant's health interests;
At screening, female participants are pregnant or breastfeeding, or male/female participants engaging in heterosexual activity plan to conceive (including sperm/egg donation) from 1 month before signing informed consent until 1 month after the last dose of the study drug, or are unable/unwilling to use effective contraception (including one or more non-pharmacological contraceptive methods or abstinence from heterosexual activity);
At screening or within 4 weeks before screening, participants are in the acute phase of HIV-1 infection or have concurrent opportunistic infections or other serious AIDS-defining conditions;
At screening or within 8 weeks before screening, resistance testing shows documented INSTI major resistance mutations, including but not limited to N155H and Q148H (as interpreted by the Stanford HIVdb database, including "low-level resistance [L]," "intermediate resistance [I]," and "high-level resistance [H]");
At screening, the investigator determines the presence of uncontrolled clinically significant diseases (including cardiovascular, respiratory, digestive, endocrine/metabolic, neuropsychiatric, hematologic, or immune system disorders), such as resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, NYHA Class III or IV heart failure, etc.;

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At screening, ALT >5× upper limit of normal (ULN), or ALT >3×ULN with total bilirubin (TBIL) >1.5×ULN or direct bilirubin (DBIL) >ULN, or other laboratory abnormalities graded ≥3 per CTCAE v5.0;
At screening, creatinine clearance <50 mL/min (calculated by Cockcroft-Gault formula);
At screening, concurrent active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection; or active syphilis infection requiring or having completed syphilis treatment <7 days prior (as judged by the investigator);
Before screening, underwent major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy), or the investigator judges that elective surgery may be required during the trial;
Screening for the past 5 years, having suffered from malignant tumors (including cervical carcinoma in situ treated with cervical conization, or surgically cured basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ [excluding Bowen's disease]);
Known history of allergy to the investigational drug, chemically similar drugs, or excipients; or a history of allergic diseases requiring medication control (such as asthma, urticaria, atopic dermatitis [eczema], etc.) prior to screening.
Within 5 years prior to screening, have a history of substance, alcohol, or other substance use disorders (excessive, inappropriate, or addictive use of substances, alcohol, or other substances for non-medical reasons, resulting in social, psychological, and physiological impairments).
Use of any prohibited medication as specified in the protocol within 14 days before the first dose of the investigational drug;
Before screening, intolerance to venipuncture, history of needle or blood phobia, or blood donation (including component donation) or significant blood loss (≥400 mL) or transfusion within 3 months before screening, or planned donation during the trial;
Within 3 months prior to screening, have participated in any interventional clinical trials, including but not limited to drugs, vaccines, or medical devices (referring to subjects who have signed the informed consent form and received the investigational drug/device or placebo).

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Clinical Center for Public Health
Shanghai

Other trials in China

About this study

Official title: Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance Mutations: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

The study consists of two treatment phases: a functional monotherapy period (double-blind phase) and an extended optimized treatment period (open-label phase).

The first phase is the functional monotherapy period (W1-W2). After initial screening, eligible participants will return to the hospital on D1 for final eligibility review and baseline examinations. Those who pass the review will be randomized in a 2:1 ratio to either ACC017 tablets (N=8, 40 mg, once daily [QD]) or matching placebo (N=4), replacing the core NNRTI drug in the failing background regimen while maintaining the original backbone NRTIs unchanged. Treatment will continue for 2 weeks.

The second phase is the extended optimized treatment period (W3-W16). All participants who complete the functional monotherapy period will receive ACC017 tablets (40 mg QD) in combination with an optimized backbone regimen (i.e., ACC017 replaces the core NNRTI drug in the failing background regimen, while the investigator adjusts the backbone drugs based on HIV genotypic resistance test results to ensure at least one backbone NRTI remains sensitive, if applicable). Treatment will continue for 14 weeks.

Conditions: Infection, Human Immunodeficiency Virus
Being tested: ACC017, Placebo
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.

ACC017Drug
ACC017
PlaceboDrug
Placebo

Study groups in NCT07711210
Study group	Role	What they receive
ACC017 group	Experimental	Participants receive ACC017 for the initial 2-week double-blind phase and continue to receive ACC017 in the subsequent open-label extension phase. Receives: Drug: ACC017
Placebo-ACC017 group	Placebo comparator	Participants receive matching placebo for the initial 2-week double-blind phase, and then switch to ACC017 in the subsequent open-label extension phase. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the percentage of participants achieving HIV-1 RNA <50 copies/mL at 16 weeks of treatment.
Measured: Week 16

Secondary outcomes (10)

To evaluate the change from baseline in HIV-1 RNA (log10 copies/mL) at 2 weeks of treatment;
Measured: Week 2
To evaluate the time-course change in the percentage of participants achieving HIV-1 RNA <50 copies/mL during treatment
Measured: week 1 - week 16
To evaluate the time-course change from baseline in HIV-1 RNA (log10 copies/mL) during treatment
Measured: week 1 - week 16
To evaluate the change from baseline in CD4+ T-cell count at 16 weeks of treatment
Measured: week 16
To evaluate the time-course change from baseline in CD4+ T-cell count (cells/μL) during treatment
Measured: week 1 - week 16
Incidence of Adverse Events (AEs)
Number and percentage of participants with treatment-emergent adverse events (TEAEs) during the study period.
Measured: week 1 - week 16
Participants with Clinically Significant Laboratory Test Abnormalities
Number of participants with clinically significant abnormalities in laboratory test results (including hematology and chemistry panels) during the study period.
Measured: week 1 - week 16
Participants with Clinically Significant Abnormal Vital Signs
Number of participants with clinically significant abnormalities in vital signs (including blood pressure, heart rate, respiratory rate, and body temperature) during the study period.
Measured: week 1 - week 16
Participants with Clinically Significant Abnormal Physical Examination Findings
Number of participants with clinically significant new or worsened abnormalities on physical examination during the study period.
Measured: week 1 - week 16
Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Number of Participants with Clinically Significant QT Interval Prolongation on 12-Lead ECG
Measured: week 1 - week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 202530 Dec 2027

First posted17 Jul 2026
Study start21 Mar 2025
Primary completion30 Jun 2027 (estimated)
Study completion30 Dec 2027 (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
Model description: double blinded in the stage one, open in the stage two
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07711210
Sponsor's protocol ID: ADYY-ACC017-202
Status last verified: Jul 2026
First submitted: 7 Jul 2026
Last updated: 17 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infection, Human Immunodeficiency Virus trials

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: Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance Mutations: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
ClinicalTrials.gov ID: NCT07711210
Acronym / sponsor ID: ADYY-ACC017-202
Conditions: Infection, Human Immunodeficiency Virus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 12 participants (actual)
Lead sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Mar 2025 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Dec 2027 (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.

The study consists of two treatment phases: a functional monotherapy period (double-blind phase) and an extended optimized treatment period (open-label phase).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: double blinded in the stage one, open in the stage two

Arm	Type	Receives
ACC017 group	Experimental	Drug: ACC017Participants receive ACC017 for the initial 2-week double-blind phase and continue to receive ACC017 in the subsequent open-label extension phase.
Placebo-ACC017 group	Placebo comparator	Drug: PlaceboParticipants receive matching placebo for the initial 2-week double-blind phase, and then switch to ACC017 in the subsequent open-label extension phase.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Voluntarily sign the informed consent form before screening and be able to comply with the protocol procedures or agreed requirements;
Age ≥18 years (inclusive) at the time of signing the informed consent, regardless of gender;
Diagnosed with HIV-1 infection before screening, having received the current first-line antiretroviral therapy (i.e., one NNRTI combined with two NRTIs) for at least 6 months (changes in treatment regimen due to tolerability issues or other adverse reactions are acceptable), with treatment interruption ≤4 weeks before screening (if applicable);
Before and at screening, no prior use of INSTI, PI, or other novel antiretroviral drugs (including but not limited to fusion inhibitors [FI] or capsid inhibitors [CAI]), including for pre-exposure prophylaxis (PrEP) and/or post-exposure prophylaxis (PEP);
At least one HIV-1 RNA test result ≥400 copies/mL within 8 weeks before screening, and confirmed HIV-1 RNA ≥400 copies/mL at screening (with ≥7 days between the two tests); or at least one HIV-1 RNA test result ≥50 copies/mL to <400 copies/mL within 8 weeks before screening, and confirmed HIV-1 RNA ≥1000 copies/mL at screening (with ≥7 days between the two tests);

Key exclusion criteria (16 listed)

The investigator judges that the participant has poor treatment compliance or protocol adherence, or any other condition that makes them unsuitable for participation, or that participation may not maximize the participant's health interests;
At screening, female participants are pregnant or breastfeeding, or male/female participants engaging in heterosexual activity plan to conceive (including sperm/egg donation) from 1 month before signing informed consent until 1 month after the last dose of the study drug, or are unable/unwilling to use effective contraception (including one or more non-pharmacological contraceptive methods or abstinence from heterosexual activity);
At screening or within 4 weeks before screening, participants are in the acute phase of HIV-1 infection or have concurrent opportunistic infections or other serious AIDS-defining conditions;
At screening or within 8 weeks before screening, resistance testing shows documented INSTI major resistance mutations, including but not limited to N155H and Q148H (as interpreted by the Stanford HIVdb database, including "low-level resistance [L]," "intermediate resistance [I]," and "high-level resistance [H]");
At screening, the investigator determines the presence of uncontrolled clinically significant diseases (including cardiovascular, respiratory, digestive, endocrine/metabolic, neuropsychiatric, hematologic, or immune system disorders), such as resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, NYHA Class III or IV heart failure, etc.;

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
ACC017ACC017	Drug	ACC017 group
PlaceboPlacebo	Drug	Placebo-ACC017 group

Primary outcome

To evaluate the percentage of participants achieving HIV-1 RNA <50 copies/mL at 16 weeks of treatment.
Time frame: Week 16

10 secondary outcomes

To evaluate the change from baseline in HIV-1 RNA (log10 copies/mL) at 2 weeks of treatment;
Time frame: Week 2
To evaluate the time-course change in the percentage of participants achieving HIV-1 RNA <50 copies/mL during treatment
Time frame: week 1 - week 16
To evaluate the time-course change from baseline in HIV-1 RNA (log10 copies/mL) during treatment
Time frame: week 1 - week 16
To evaluate the change from baseline in CD4+ T-cell count at 16 weeks of treatment
Time frame: week 16
To evaluate the time-course change from baseline in CD4+ T-cell count (cells/μL) during treatment
Time frame: week 1 - week 16
Incidence of Adverse Events (AEs)
Time frame: week 1 - week 16
Participants with Clinically Significant Laboratory Test Abnormalities
Time frame: week 1 - week 16
Participants with Clinically Significant Abnormal Vital Signs
Time frame: week 1 - week 16
Participants with Clinically Significant Abnormal Physical Examination Findings
Time frame: week 1 - week 16
Participants with Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Time frame: week 1 - week 16

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. This study is not recruiting at the moment.

Zhang R Fang principal investigator

Shanghai Clinical Center for Public Health

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 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 9 inclusion and 16 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: under way, not looking for participants, 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. Some participants in this study may receive a placebo. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the percentage of participants achieving HIV-1 RNA <50 copies/mL at 16 weeks of treatment. (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07711210.

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.