HIV-1 infection
Conditions
Interventions
Group A:CAR-T cell therapy combined with HAART therapy
Group C:Anti-gp120 CAR-T therapy alone
Group B:HAART alone (TDF+3TC+EFV)
Sponsors
Kunming Third People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Subjects fully understand the purpose, nature, methods, and possible adverse reactions of the trial, volunteer to be subjects, and sign an informed consent form before any research procedures begin; 2.Male and female subjects aged 18 to 65 years (including 18 and 65 years old); 3.Male weight >= 50.0 kg, female weight >=45.0 kg; 4.HIV-1 antibody test is positive; 5.The HIV viral load is between 1x10^4-1x10^6cp/mL; 6.Infected patients with peripheral CD4+T cells >200/µL; 7.The patient's important tissues and organs function well, and the relevant indicators meet the following requirements: (1)Liver function: ALT/AST 80 mL/min; (3)Heart function: Left ventricular ejection fraction (LVEF) >=40%; (4)The blood routine showed no significant abnormality in the indicators of white blood cells, platelets, and hemoglobin. 8.There is no abnormality in head CT and EEG.
Exclusion criteria
Exclusion criteria: 1.Patients who have received any HIV antiviral treatment; 2.Used immunomodulators, cytokines or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibodies, IFN, interleukin 2 (IL) within 90 days of screening -2); patients with anticoagulant drugs such as coumarin, warfarin or other coumarin derivatives; 3.Patients who received any intravenous blood products, immunoglobulin or hematopoietic growth factor within 90 days before enrollment; 4.Patients cannot be guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment; 5.Women who are pregnant (positive blood pregnancy test) or breastfeeding; 6.Patients suffering from malignant tumors, autoimmune diseases, uncontrolled diabetes, hypertension, abnormal heart, liver, lung and kidney function, or other serious organic diseases; 7.Patients with other systemic active infections that require treatment, including syphilis, active tuberculosis, and clinically active hepatitis A, B, and C; 8.Unable to communicate or cooperate with medical staff due to neurological, mental illness or language barriers; 9.The patient has participated in or is currently participating in other clinical trials within three months before enrollment; 10.Patients have a history of drug abuse within 6 months before screening; 11.Patients who are banned drugs who are receiving HAART treatment at the same time; 12.The patient is allergic and is allergic to macromolecular biological drugs such as antibodies or cytokines; 13.Anyone determined by the researcher to be unsuitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in plasma ribonucleic acid levels of Human Immunodeficiency virus;Changes in CD4 positive T lymphocyte count;Changes in CD8 positive T lymphocyte count;Changes of CD4+T/CD8+T ratio;Intracellular HIV-1 P24 antigen quantification, intracellular viral total and integrated deoxyribonucleic acid levels and total ribonucleic acid levels;The size of the virus library was detected by virus growth assay;Amplification effect and persistence of chimeric antigen receptor T cells in subjects;Immunological evaluation index; | — |
Countries
China
Contacts
Public ContactBai Jingsong/Liu Jun
Kunming Third People's Hospital
Outcome results
None listed