Evaluating ACC017 tablets for treating HIV infection

A Phase Ib/IIa, Randomized, Double Blinded, Perallel, Dosing Ranging, Placebo Controled and Proof of Concept Clinical Trial to Evaluate the Safety, Tolerability, PK and Antiviral Effect of ACC017 Tablet as Monotherapy/Combination With NRTI in Treatment naïve HIV-infected Adults

This study is testing a new HIV medication called ACC017 to see how safe it is and how well it works in adults who have never been treated before.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu Aidea Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06719310 on ClinicalTrials.gov

What this trial studies

This phase Ib/IIa clinical study aims to assess the safety, tolerability, pharmacokinetics, and antiviral effects of ACC017, an integrase inhibitor, in treatment-naïve adults infected with HIV-1. The study is designed in two stages: the first stage involves a dose-ranging evaluation of ACC017 monotherapy over 10 days, while the second stage combines ACC017 with FTC/TAF for an additional 18 days. Participants will be randomized to receive either ACC017 at varying doses or a placebo, with a focus on determining the optimal dose for future trials.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve adults aged 18 to 65 with documented HIV-1 infection and specific health criteria.

Not a fit: Patients with acute HIV infection or those who have received prior anti-HIV treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with HIV infection.

How similar studies have performed: Other studies have shown promise with integrase inhibitors, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Willing to sign the informed consent and agree to comply to the study procedures and requests
2. Age range between 18 and 65 years old at the time of signing informed consent, regardless of gender
3. Body weight ≥40 kg, and BMI range between 18.5\~29.9 kg/m2 (including the borderline) at screening
4. Documented HIIV-1 infection before screening, and never receive any antiHIV-1 drugs or vaccines after the diagnosis of HIV-1 infection
5. Agree not to use any antiviral drugs other than those allowed by protocol during study period.
6. Plasma HIV RNA≥5000 copies/mL at screening;
7. CD4+ T-lymphocyte count of \>200 cells/μL

Exclusion Criteria:

1. Diagnosis of acute HIV infection at screening or unstable AIDS related disease within 4 weeks prior to screening.
2. Had PrEP and/or PEP treatment within 1 month prior to screening.
3. Had uncontrolled severe disease judged by investigator, such as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, NYHA class III or IV or fasting glucose ≥7.0 mmol/L.
4. History of serious allergy to drugs (such as aspirin or cephalosporin antibiotics) or their ingredients' or food (a fast, life-threatening systemic allergic reaction), or allergic disease requiring drug control (such as asthma, urticaria, atopic dermatitis \[eczema\].).
5. Any major gastrointestinal surgery (except uncomplicated appendectomy or cholecystectomy) or any surgery affecting drug absorption, distribution, metabolism and excretion within 6 months before screening; or possible elective surgery during the trial as judged by the investigator.
6. History of cancer(except cervical carcinoma in situ, or cutaneous basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ \[Bowen's disease\] that received radical surgery or treatment) within 5 years prior to screening.
7. Hb \<90 g/L, or WBC count \<1.5×109/L, or ANC count \<0.6×109/L, or platelet count \<50×109/L at screening.
8. ALT and/or AST \> 2.5 times upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or DBIL \> ULN, or ALB \<30 g/L at screening.
9. SCr \> 1.3 ×ULN, or Ccr \<60 mL/min (Cockcroft-Gault formula) at screening,
10. Blood amylase or lipase \>1.5 ×ULN
11. Subjects with a positive for HBsAg or anti-HCV, or those with anti-Tp positive who need to be treated required by investigator or their treatment period \<7 days at screening.
12. Average smoked cigarettes more than 5 a day within 3 months prior to screening or unwilling to stop using any tobacco products during hospitalization.
13. Drinking more than 14 units per week within 3 months prior to screening ( 1 unit of alcohol is equivalent to 5% beer, 45 mL of 40% alcohol, 150mL of 12% alcohol), or a positive alcohol breath test at a screening or baseline visit, or unwilling to stop drink any alcohol-containing product during hospitalization.
14. Excessive consumption of tea, coffee or caffeine ( more than 8 cups per day on average, 1 cup of 250 mL) or unwilling to stop drinking tea, coffee, or caffeine during hospitalization.
15. Having taken pitaya, mango, grapefruit, star fruit or any preparations made from them, or food/drinking containing xanthine, caffeine or alcohol (e.g.chocolate, tea, coffee, cola and cocoa) or others that will affect the absorption, distribution, metabolism, excretion of drugs, within 48 hours prior to the first dose of experimental drugs, or unwilling to stop taking them during hospitalization.
16. Use of any potent or moderate CYP3A inhibitors (e.g. clarithromycin, thalimycin, ketocomazole, ketoconazole, itraconazole, and CYP3A4) or potent CYP3A4 inducers (e.g. rifampin, efavirenz,carbamazepine, phenobarbitone, phenytoin) within 14 days prior to the first dose of experimental drugs or within 5 half-lives(whichever is longer).
17. Use of any potent or moderate UGT1A inhibitors (e.g. silybin. Ritonavir) or potent UGT1A1 inducers (e.g. rifampin, carbamazepine) within 14 days prior to the first dose of experimental drugs or within 5 half-lives (whichever is longer).
18. Use of any prescription drug, nonprescription drug, Chinese traditional herbs within 14 days prior to the first dose of experimental drugs or within 5 half-lives (whichever is longer).
19. History of drug dependence (social, psychological and physical impairment due to excessive, impropriate or addictive use of substances for any non-medical reason) within 5 years prior to screening, or positive urine drug screen at screening or baseline.
20. Intolerance to venipuncture, or have a history of halo acupuncture or blood sickness, or have donated blood including component blood or have had substantial blood loss (more than 400 mL) or have received a blood transfusion within 3 months prior to screening, or plan to donate blood during study.
21. Have special dietary requirements at screening, or refuse to accept a standard diet.
22. Have participated in or are participating in another drug or medical device clinical study within 3 months prior to screening.
23. Women who are pregnant or breastfeeding or who have a positive blood pregnancy test at screening.
24. Have a birth plan (including conception, eggs or sperm donation) within 1 month before signing informed consent form until 3 months after last dose of experimental drugs or refuse to use effective any contraceptive methods.
25. Other conditions exist that, in the judgement of the investigator, make participation in this study unsuitable.

Where this trial is running

Beijing

• Beijing Ditan Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Zhang Fujie, M.D., Ph.D. — Beijing Ditan Hospital
• Study coordinator: Qin Hong, M.D., Ph.D.

Conditions Infection, Human Immunodeficiency Virus