Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

Exclusion Criteria

• •Have suffered from any serious acute disease within 8 weeks;
• •Subjects with a history of active autoimmune disease or autoimmune disease requiring systemic treatment;
• •Pre-treatment/exposure to any other immune checkpoint inhibitor \[e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.\].
• •The patient has received the following treatment:
• •1. Received other anti-latency drugs within 30 days prior to enrollment;
• •2. Radiotherapy or chemotherapy 30 days before screening;
• •3. Immunosuppressive therapy 60 days before screening;
• •4. Treatment with immunomodulators (e.g., interleukin, interferon), hydroxyurea, or phosphonic acid 60 days prior to screening
• •5. Receiving HIV vaccine or systemic cytotoxic chemotherapy 60 days before screening;
• •6. Previous immunoglobulin (IgG) therapy
• •7. Received blood transfusion or cell growth factor therapy in the 90 days prior to screening
• •8. Drugs such as rifampicin and rifambutin were being used at the time of screening or at the planned treatment stage;
• •Laboratory tests meet the following standards:
• •1. Absolute neutrophil count (ANC) \< 1.50×109/L; Hemoglobin (Hb) \< 105g/L(male) or \< 95g/L(female); Platelet \< 75×109/μL; International Normalized Ratio (INR) \> 1× Upper Limit of Normal (ULN)
• •2. Serum alanine aminotransferase (ALT) \> 1.5× upper limit of normal (ULN), serum aspartate aminotransferase (SGOT/AST) \> 1.5× upper limit of normal (ULN), total bilirubin, direct bilirubin \> 1.5× upper limit of normal (ULN), serum creatinine \> 1.5× upper limit of normal (ULN), And the abnormality has clinical significance;
• •3. Five abnormalities of thyroid function with clinical significance: test items include triiodothyronine (T3), tetraiodothyronine (T4), free triiodothyronine (FT3), free tetraiodothyronine (FT4), and thyroid stimulating hormone (TSH).
• •4. The epinephrine test was abnormal and clinically significant;
• •5. Blood glucose and glycated hemoglobin were abnormal and clinically significant
• •Twelve-lead electrocardiogram was abnormal and clinically significant at the time of enrollment;
• •Interstitial changes were detected by chest CT at the time of enrollment;
• •Subjects with severe heart disease, symptomatic or asymptomatic arrhythmia;
• •Patients with co-infection such as HBV, HCV, syphilis, diabetes, and other liver diseases;
• •Subjects with a history of active or suspected malignancy or malignancy (other than basal cell skin cancer or cervical cancer in situ) within five years.
• •Subjects with a history of tuberculosis or active tuberculosis.
• •Subjects with psychiatric or substance abuse disorders known to interfere with the requirements of the experiment.
• •Subjects who received immunomodulatory or immunosuppressive therapy in the 24 weeks prior to first taking the study drug.
• •Pregnant and lactating women;
• •Mental illness or drug abuse interferes with the conduct of the test.
• •Histone deacetylase inhibitors, such as valproic acid, butyrate, phenyl butyrate, etc., but can be included after a 28-day washout period;
• •Patients with severe cardiac insufficiency \[New York College of Cardiology (NYHA) Grade IV for cardiac insufficiency\];
• •any arterial thromboembolism event, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to treatment induction; Standardized treatment of uncontrolled hypertension (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); Cardiomyopathy;
• •Patients had significant QT/QTC intervals during the screening period (Fridericia formula: QTcF=QT/RR0.33) prolonged (e.g., repeated measurements show a QTc interval \>450 ms, or there is another risk of torsive ventricular TdP \[e.g., heart failure, hypokalemia, familial long QT syndrome\]) or combined use of drugs that may cause a prolonged QT/QTc interval;
• •Allergic or anti-drug antibodies to the drug or excipient used in this test are known.
• •The researchers judged that they were not suitable to participate in this experiment.