Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
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|ClinicalTrials.gov Identifier: NCT03980691|
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Biological: Chidamide with CAR-T or TCR-T cell therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The control arm includes HIV-infected patients without receiving cellar therapy combined with Chidamide whose HIV-1 has been successfully suppressed after cART.|
|Masking:||None (Open Label)|
|Official Title:||Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Chidamide combined with CAR-T or TCR-T cell therapy
Receiving chidamide combined with CAR-T or TCR-T cell therapy based on 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.
Biological: Chidamide with CAR-T or TCR-T cell therapy
HIV-1 specific therapy
No Intervention: without intervention
Not receiving chidamide combined with CAR-T or TCR-T cell therapy but continuing 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.
- Incidence of treatment-associated adverse events [ Time Frame: 6 Months ]To observe the adverse events of intervention n HIV-infected patients during the study.
- HIV reservoir [ Time Frame: 6 Months ]To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
- HIV-specific immunity [ Time Frame: 6 Months ]The number of HIV-specific CD4,CD8,VC-CAR-T and TCR-T cells after receiving the therapy.
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): NCT03980691
|Contact: Linghua Li, Doctorfirstname.lastname@example.org|
|Contact: Weiping Cai, Bacheloremail@example.com|
|Guangzhou 8th People's Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Linghua LI, Doctor 020-83710825 firstname.lastname@example.org|
|Principal Investigator:||Weiping Cai, Bachelor||Guangzhou 8th People's Hospital China, Guangdong|