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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 : Completed
First Posted : June 10, 2019
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
Incidence of treatment-associated adverse events [ Time Frame: 6 Months ]
To observe the adverse events of intervention n HIV-infected patients during the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
HIV reservoir [ Time Frame: 6 Months ]
To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
Official Title  ICMJE Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Biological: Chidamide with CAR-T or TCR-T cell therapy
HIV-1 specific therapy
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Chidamide with CAR-T or TCR-T cell 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2021)
4
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
40
Actual Study Completion Date  ICMJE May 31, 2020
Actual Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980691
Other Study ID Numbers  ICMJE 20171126V1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linghua LI, Guangzhou 8th People's Hospital
Study Sponsor  ICMJE Guangzhou 8th People's Hospital
Collaborators  ICMJE Sun Yat-sen University
Investigators  ICMJE
Principal Investigator: Weiping Cai, Bachelor Guangzhou 8th People's Hospital China, Guangdong
PRS Account Guangzhou 8th People's Hospital
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP