The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients

Inclusion criteria

• Age between 18 and 65 years;
• Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels \<50 copies/mL for the 12 months preceding enrollment;
• CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
• Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have no plans for conception and must voluntarily adopt effective contraceptive measures;
• Willingness to provide true identity information and comply with follow-up requirements;
• Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.

Exclusion criteria

• Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
• Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
• History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
• Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
• Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or malignancies.
• Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
• Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
• Abnormal laboratory results within 14 days prior to enrollment meeting any of the following:
• Hemoglobin \<10 g/dL (female) or \<11 g/dL (male) Absolute neutrophil count \<1 ×10⁹/L Platelet count \<100 ×10⁹/L Serum creatinine \>110 μmol/L INR \>1.5 or PTT \>45 seconds ALT or AST \>2.5 × upper limit of normal (ULN) Total bilirubin \>1.5 × ULN
• Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
• Any other condition deemed inappropriate for participation by the investigator.