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OpenTrials
Completed

NCT Number: NCT03980691

Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Chidamide with CAR-T or TCR-T cell therapy

Biological

HIV-1 specific therapy

Primary outcomes

  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 outcomes

  1. HIV reservoir

    Time frame: 6 Months

    To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Collaborators

  • Sun Yat-sen University

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2019
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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