Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
Verified June 2019 by Linghua LI, Guangzhou 8th People's Hospital
Guangzhou 8th People's Hospital
Sun Yat-sen University
Information provided by (Responsible Party)
Linghua LI, Guangzhou 8th People's Hospital
First received: June 7, 2019
Last updated: June 7, 2019
Last Verified: June 2019
History of Changes
To study the safety and effectiveness of the combination of Chidamide with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy on HIV patients based on cART.
Biological : Chidamide with CAR-T or TCR-T cell therapy
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)
Primary Purpose: Treatment
|Official Title:||Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir|
Further study details as provided by Linghua LI, Guangzhou 8th People's Hospital:
Primary Outcome Measures
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.
|Study Start Date:||December 1, 2017|
|Estimated Study Completion Date:||December 31, 2021|
|Estimated Primary Completion Date:||December 31, 2020 (Final data collection date for primary outcome measure)|
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.
Chidamide with CAR-T or TCR-T cell therapy
HIV-1 specific therapy
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.
Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to cure human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which such reservoirs are eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells. Some studies have shown that Chidamide can highly activate the HIV reservoirs. The VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving suppressive cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. The purpose of this study is to evaluate the safety and efficacy of Chidamide together with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy based on cART in HIV-infected adults whose plasma HIV has been successfully suppressed after cART.Eligibility
|Ages Eligible for Study:||18 Years to 60 Years|
|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.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03980691
|Contact: Linghua Li, Doctoremail@example.com|
|Contact: Weiping Cai, Bachelorfirstname.lastname@example.org|
Locations Show More
|Guangzhou 8th People's Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510060|
Contact: Linghua LI, Doctor  020-83710825  email@example.com
Sponsors and CollaboratorsGuangzhou 8th People's Hospital
Sun Yat-sen University
|Principal Investigator:||Weiping Cai, Bachelor||Guangzhou 8th People's Hospital China, Guangdong|
|Responsible Party:||Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital|
|ClinicalTrials.gov Identifier:||NCT03980691 History of Changes|
|Other Study ID Numbers:||20171126V1|
|Study First Received:||June 7, 2019|
|Last Updated:||June 7, 2019|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:Chidamide,CAR cell therapy,TCR cell therapy
ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.