The Effect of Chimeric Antigen Receptor (CAR)-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
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|ClinicalTrials.gov Identifier: NCT03240328|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : September 14, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Biological: CAR-T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||No control.|
|Masking:||None (Open Label)|
|Official Title:||The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function|
|Actual Study Start Date :||October 4, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2030|
Experimental: CAR-T therapy
Transfusing CAR-T cells at least 1 million clone every time (once or twice) based on cART after attaining plasma HIV suppression (plasma HIV RNA <50 cp/ml) and CD4+ cell count more than 350 cells/ul over 1 year by cART without active HCV or HBV infection or opportunistic infections. If the candidates reach the criteria of discontinuing cART, they will stop cART and receive close observation. Once the plasma HIV viral load rebound to over 1000 cp/ml, they will restart cART immediately.
Biological: CAR-T cells
HIV-1 specific chimeric antigen receptor cells
- Incidence of treatment-associated adverse events of CAR-T cell therapy [ Time Frame: 6 Months ]To observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial
- HIV-1 reservoir [ Time Frame: 6 Months ]To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
- HIV viral load rebound time [ Time Frame: 6 months ]To assay the HIV viral load rebound period after discontinuing cART
- HIV-specific immunity [ Time Frame: 6 Months ]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
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- The subjects know about the study and volunteer to attend the research and sign the informed consent.
- 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.
- With poor adherence.
- Unable to complete follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240328
|Contact: Li Linghua, Doctoremail@example.com|
|Contact: Cai Weiping, Bachelorfirstname.lastname@example.org|
|Guangzhou 8th People's Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Linghua LI, doctor 020-83710825 email@example.com|
|Principal Investigator:||Cai Weiping, Bachelor||Guangzhou 8th People's Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital|
|Other Study ID Numbers:||
|First Posted:||August 7, 2017 Key Record Dates|
|Last Update Posted:||September 14, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
CAR-T HIV therapy
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases