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NCT Number: NCT03240328

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangzhou 8th People's Hospital

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Linghua LI, doctor

CONTACT

[email protected]

020-83710825

About this study

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.

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

CAR-T cells

Biological

HIV-1 specific chimeric antigen receptor cells

Primary outcomes

  1. Incidence of treatment-associated adverse events of CAR-T cell therapy

    Time frame: 6 Months

    To observe the adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial

Secondary outcomes

  1. HIV-1 reservoir

    Time frame: 6 Months

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

  2. HIV viral load rebound time

    Time frame: 6 months

    To assay the HIV viral load rebound period after discontinuing cART

Other outcomes

  1. HIV-specific immunity

    Time frame: 6 Months

    To assay the remaining concentration of VC-CAR-T cells in patients, the number of HIV-specific CD4,CD8 and their activity after receiving CAR-T cell therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Cai Weiping, Bachelor

CONTACT

[email protected]

020-83710816

Li Linghua, Doctor

CONTACT

[email protected]

020-83710825

Sponsors and collaborators

Lead sponsor

Guangzhou 8th People's Hospital

Other

Collaborators

  • Sun Yat-sen University

Registry information

Official study title

The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function

Important dates

Study start
2017
Primary completion
2023
Study completion
2030
First posted
Aug 7, 2017
Registry last updated
Sep 14, 2022

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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