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Reconstitution of HIV-specific Immunity Against HIV

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ClinicalTrials.gov Identifier: NCT02563509
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : May 23, 2017
Sun Yat-sen University
Information provided by (Responsible Party):
Linghua LI, Guangzhou 8th People's Hospital

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reconstitution of HIV-specific Immunity Against HIV
Study Start Date : January 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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).

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.

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

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

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

Contact: LingHua LI, doctor 13725297174 llheliza@126.com

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
Principal Investigator: Hui Zhang, doctor Sun Yat-sen University


Responsible Party: Linghua LI, Chief physician, Guangzhou 8th People's Hospital
ClinicalTrials.gov Identifier: NCT02563509     History of Changes
Other Study ID Numbers: 2013ZX10001004
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
cellular immunity therapy
functional cure