Reconstitution of HIV-specific Immunity Against HIV

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reconstitution of HIV-specific Immunity Against HIV

Conditions
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HIV

Intervention / Treatment
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* Biological: HIV-specific CD8 cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV infection confirmed Receiving HAART more than 6 months HIV viral-load < 50 copies/ml Without serious damage of liver and kidney The subject volunteered to the research and sign the informed consent Exclusion Criteria: With serious opportunistic infections With serious chronic disease such like diabetes, the mental illness,et al History of suffering from pancreatitis during HAART. Pregnant and breast-fed. With poor adherence

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV-specific CD8 cells<br>Transfusing HIV-specific CD8 cells 50-100mlonce a week for four times. | Biological: HIV-specific CD8 cells<br>* Based on HAART, receive HIV-specific CD8 cells transfuion.<br>|
| No Intervention: Regualar therapy<br>Only receiving Highly active anti-retroviral therapy(HAART). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and function of HIV-specific CD8 cells in patients with HIV | The change of differentiation, proliferation, apoptosis, phenotype, etal. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events | Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, cellular immunity therapy, functional cure