Clinical trial NCT02563509: Reconstitution of HIV-specific Immunity Against HIV
Official title: Reconstitution of HIV-specific Immunity Against HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Keywords: HIV
cellular immunity therapy
functional cure
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2015-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The number and function of HIV-specific CD8 cells in patients with HIV
timeFrame: 6 Months
Secondary outcomes:
measure: All adverse events
timeFrame: 6 Months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou 8th People's Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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