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Reconstitution of HIV-specific Immunity Against HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563509
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

Study Description
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Brief Summary:
Research Goal: To reconstitute the anti-HIV specific immunity system of the AIDS patients, so the viruses could not massively replicate when HAART was discontinued, then make HIV functional cure possible.

Condition or disease Intervention/treatment Phase
HIV Biological: HIV-specific CD8 cells Phase 1

Detailed Description:
The research aims at establishing a new treatment strategies of HIV. It will significantly improve the clinical therapy effects and effectively reduce the morbidity and mortality by reconstituting the immune systems of HIV infected patients and combining multiple therapy strategies. Therefore, the research could develop an cloning amplification system of immunocytes in vitro, and improve the antiviral immune system severely damaged before by transfusing the clone cells modified by specific HIV antigen. So HIV infected patients could discontinue the traditional anti-viral drug, but not develop opportunistic infections,which could obviously increase the life qualities of these patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstitution of HIV-specific Immunity Against HIV
Actual Study Start Date : January 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: HIV-specific CD8 cells
Transfusing HIV-specific CD8 cells 50-100mlonce a week for four times.
 Biological: HIV-specific CD8 cells
Based on HAART, receive HIV-specific CD8 cells transfuion.
No Intervention: Regualar therapy
Only receiving Highly active anti-retroviral therapy(HAART).


Outcome Measures
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Primary Outcome Measures :
  1. The number and function of HIV-specific CD8 cells in patients with HIV [ Time Frame: 6 Months ]
    The change of differentiation, proliferation, apoptosis, phenotype, etal.


Secondary Outcome Measures :
  1. All adverse events [ Time Frame: 6 Months ]
    Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.


Eligibility Criteria
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Information from the National Library of Medicine

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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.
  5. With poor adherence
Contacts and Locations
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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): NCT02563509


Locations
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China, Guangdong
Guangzhou 8th People's Hospital
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Guangzhou 8th People's Hospital
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Zhang, doctor Sun Yat-sen University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Linghua LI, Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT02563509    
Other Study ID Numbers: 2013ZX10001004
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
HIV
cellular immunity therapy
functional cure