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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03980691

Enrollment

Registered

2019-06-10

Start date

2017-12-01

Completion date

2020-05-31

Last updated

2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

Chidamide,CAR cell therapy,TCR cell therapy

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.

Interventions

BIOLOGICALChidamide with CAR-T or TCR-T cell therapy

HIV-1 specific therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-associated adverse events	6 Months	To observe the adverse events of intervention n HIV-infected patients during the study.

Secondary

Measure	Time frame	Description
HIV reservoir	6 Months	To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma

Other

Measure	Time frame	Description
HIV-specific immunity	6 Months	The number of HIV-specific CD4,CD8,VC-CAR-T and TCR-T cells after receiving the therapy.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026