Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults Wi… (NCT07711210) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance Mutations
China12 participantsStarted 2025-03-21
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the percentage of participants achieving HIV-1 RNA <50 copies/mL at 16 weeks of treatment.
Timeframe: Week 16
Trial details
NCT IDNCT07711210
SponsorJiangsu Aidea Pharmaceutical Group Co., Ltd.
. 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.
Exclusion 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.;
. 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);