HIV infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females, age between 18 and 50 years, with a male-to-female ratio of approximately 1:1. 2. The time interval between the initial initiation of ART and the last follow-up for enrolled patients did not exceed 8 years. 3. Patients with confirmed HIV-1 infection; 4. A duration of ART treatment of no less than two years was required, with closely matched durations of both HIV infection and ART experience across the enrolled patient cohort; 5. An undetectable viral load was maintained for more than two consecutive years, with no viral rebound during this period; 6. Informed consent was obtained from all patients or their relatives prior to the enrollment in this study; 7. The antiretroviral therapy comprised either TDF + 3TC + EFV or AZT + 3TC + NVP; 8. Patients with complete immune reconstitution (IRs): peripheral blood CD4+ T-cell count > 500 cells/µL. Patients with incomplete immune reconstitution (INRs): peripheral blood CD4+ T-cell count 500/µ l, HIV-1 and HIV-2 antibody testing negative (not infected). 3. Not participating in other clinical trials.
Exclusion criteria
Exclusion criteria: 1. Patient ages below 18 years or above 50 years; 2. Infected by pathogens such as hepatitis viruses, syphilis, sexually transmitted diseases, or herpes simplex virus that have not been cured; 3. Tuberculosis infection; 4. Patients with severe hepatic, renal, cardiac, or cerebral dysfunction, or serious complications such as hypertension, diabetes mellitus, or coronary heart disease; those with severe acute infections that are uncontrolled, or those with suppurative and chronic infections, or non-healing wounds; those with uncontrolled central nervous system metastatic tumors, presenting with significant symptoms of intracranial hypertension or neuropsychiatric symptoms; 5. Poor adherence to ART.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of proliferation, activation, cell cycle, and apoptosis in co-cultured CD4+ T cells;Atlas of immune cell clusters from single-cell RNA sequencing;The quantity and function of primary MAIT cells;Clonotypes specific to the INRs and IRs groups in T- and B-cell immune repertoires;Expression levels of CAR molecules on MAIT cells;Analyses of cell cycle and apoptosis in naive B cells (CFSE/PI staining);Measurement of secreted IgG antibody levels (IgG1, IgG2, IgG3, IgG4);Cytotoxic activity against HIV-1 latent target cells (CD4+ T, ACH2 cells) by CAR-MAIT cells; | — |
Secondary
| Measure | Time frame |
|---|---|
| The inflammatory cytokine expression (IL-2, IFN-?, TNF-a, GZMB, GM-CSF) in CAR-MAIT cells;Levels of pro-inflammatory and anti-inflammatory cytokines in peripheral blood samples;The number and proportions of naive B cells;Expression of phenotypic markers on CD4+, CD8+ T cells, including apoptosis marker (CD95), activation markers (CD38, HLA-DR, Ki67), immunosenescence marker (CD57), exhaustion marker(CD279);Detection of immunophenotypic markers on naive B cells;The secretion of inflammatory factors (IL-2, IL-4, IL-17, IFN-?, TNF-a) by co-cultured CD4+ T cells; | — |
Countries
China
Contacts
First Affiliated Hospital of Kunming Medical University