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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
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Biological: Chidamide with CAR-T or TCR-T cell therapy Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Incidence of treatment-associated adverse events [ Time Frame: 6 Months ]
    To observe the adverse events of intervention n HIV-infected patients during the study.


Secondary Outcome Measures :
  1. HIV reservoir [ Time Frame: 6 Months ]
    To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV infection confirmed
  2. Receiving cART more than 12 months.
  3. HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul.
  4. Without serious liver , heart, liver and kidney diseases.
  5. The subjects know about the study and volunteer to attend the research and sign the informed consent.

Exclusion Criteria:

  1. With active HBV or HCV infection, or serious opportunistic infections.
  2. With serious chronic disease such like diabetes, the mental illness,et al
  3. History of suffering from pancreatitis during cART .
  4. Pregnant or breast-fed.
  5. With poor adherence.
  6. Unable to complete follow up.

Information from the National Library of Medicine

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


Contacts
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Contact: Linghua Li, Doctor 020-83710825 llheliza@126.com
Contact: Weiping Cai, Bachelor 020-83710816 gz8hcwp@126.com

Locations
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China, Guangdong
Guangzhou 8th People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua LI, Doctor    020-83710825    llheliza@126.com   
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Sun Yat-sen University
Investigators
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Principal Investigator: Weiping Cai, Bachelor Guangzhou 8th People's Hospital China, Guangdong

Publications of Results:
Other Publications:
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Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT03980691     History of Changes
Other Study ID Numbers: 20171126V1
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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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