The Effect of Chimeric Antigen Receptor (CAR)-T Cell Therapy on the Reconstitution of HIV-specific Immune Function

Last updated: September 13, 2022
Sponsor: Guangzhou 8th People's Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv Infections

Hiv/aids

Aids And Aids Related Infections

Treatment

N/A

Clinical Study ID

NCT03240328
20170407V3
  • Ages 18-60
  • All Genders

Study Summary

To study the safety and effectiveness of CAR-T Cell therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, which is expected to enhance the res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.

Eligibility Criteria

Inclusion

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 theinformed consent.

Exclusion

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.

Study Design

Total Participants: 40
Study Start date:
October 04, 2017
Estimated Completion Date:
December 31, 2030

Study Description

Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to curing human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which HIV-1 reservoirs could be 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.the VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving successful 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. In this clinical trial, we intend to study the safety and effectiveness of CAR-T Cell Therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, by observing the adverse events, HIV-1 reservoir and the immune index.

Connect with a study center

  • Guangzhou 8th People's Hospital

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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