Reconstitution of HIV-specific Immunity Against HIV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HIV-specific CD8 cells

Transfusing HIV-specific CD8 cells 50-100mlonce a week for four times.

Group Type EXPERIMENTAL

HIV-specific CD8 cells

Intervention Type BIOLOGICAL

Based on HAART, receive HIV-specific CD8 cells transfuion.

Regualar therapy

Only receiving Highly active anti-retroviral therapy(HAART).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HIV-specific CD8 cells

Based on HAART, receive HIV-specific CD8 cells transfuion.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No