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Trial record 2 of 3 for:    23527958 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03240328
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Biological: CAR-T cells Phase 1

Detailed 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 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.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.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 and the immunity(CD4,Th1/Th2 and VC-CAR-T) and HIV viral load of patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The control arm includes HIV-infected patients without receiving celluar therapy whose HIV has been successfully suppressed after cART.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: CAR-T therapy
Transfuse CAR-T cells 1 million clone every time (totally twice) based on cART after attaining plasma HIV suppression (plasma HIV RNA <50 cp/ml) over 1 year by cART
Biological: CAR-T cells
HIV-1 specific chimeric antigen receptor cells

No Intervention: Without CAR-T therapy
Without CAR-T cells transfusion but continue cART after attaining plasma HIV suppression (plasma HIV RNA <50 cp/ml) over 1 year by cART.



Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events of CAR-T cell therapy [ Time Frame: 6 Months ]
    The adverse events of VC-CAR-T cell therapy on HIV-infected patients during the clinical trial


Secondary Outcome Measures :
  1. The HIV reservoir [ Time Frame: 6 Months ]
    To assay the HIV loads in the peripheral blood Mono-nuclear cells and plasma


Other Outcome Measures:
  1. The HIV-specific immunity [ Time Frame: 6 Months ]
    The number of HIV-specific CD4,CD8 and VC-CAR-T cells in patients with HIV after receiving CAR-T cell therapy



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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV infection confirmed
  2. Receiving HAART more than 6 months
  3. HIV viral-load < 50 copies/ml
  4. Without serious damage of liver and kidney
  5. The subject volunteered to the research and sign the informed consent

Exclusion Criteria:

  1. With serious opportunistic infections
  2. With serious chronic disease such like diabetes, the mental illness,et al
  3. History of suffering from pancreatitis during HAART.
  4. Pregnant and breast-fed. With poor adherence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240328


Contacts
Contact: Li Linghua, Doctor 13725297174 llheliza@126.com
Contact: Cai Weiping, Bachelor 13808815909 gz8hcwp@126.com

Locations
China, Guangdong
Guangzhou 8th People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Linghua LI, doctor    13725297174    llheliza@126.com   
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Sun Yat-sen University
Investigators
Principal Investigator: Cai Weiping, Bachelor Guangzhou 8th People's Hospital

Publications:

Responsible Party: Linghua LI, Vice Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT03240328     History of Changes
Other Study ID Numbers: 20170407V3
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linghua LI, Guangzhou 8th People's Hospital:
CAR-T HIV therapy