Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Incidence of treatment-associated adverse events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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: Chidamide with CAR-T or TCR-T cell therapy (Biological)
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.
Outcomes
Primary Outcomes
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
- HIV reservoir(6 Months)
Investigators
Linghua LI
Vice Chief physician
Guangzhou 8th People's Hospital