About this trial
To study the safety and effectiveness of CAR-T Cell therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, which is expected to enhance the res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
HIV infection confirmed.
Receiving cART more than 12 months.
HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul.
Without serious liver, heart, liver and kidney diseases.
Disqualifiers
With active HBV or HCV infection, or serious opportunistic infections.
With serious chronic disease such like diabetes, the mental illness,et al
History of suffering from pancreatitis during cART.
Pregnant or breast-fed.
Trial design
Single group
Treatments tested in this trial
CAR-T cells
Biological/VaccineHIV-1 specific chimeric antigen receptor cells
Treatment groups
Trial outcomes
Primary outcomes
Incidence of treatment-associated adverse events of CAR-T cell therapy
To observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial
Secondary outcomes
HIV-1 reservoir
To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
HIV viral load rebound time
To assay the HIV viral load rebound period after discontinuing cART
Other outcomes
HIV-specific immunity
To assay the remaining concentration of VC-CAR-T cells in patients, the number of HIV-specific CD4,CD8 and their activity after receiving CAR-T cell therapy
Sponsors and contacts
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Guangzhou 8th People's Hospital
Lead sponsor
Sun Yat-sen University
Collaborator