Reconstitution of HIV-specific Immunity Against HIV

Phase 1

Completed

• Conditions: HIV
• Interventions: Biological: HIV-specific CD8 cells

• Registration Number: NCT02563509
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Study Start: 2016-01
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The number and function of HIV-specific CD8 cells in patients with HIV	6 Months	The change of differentiation, proliferation, apoptosis, phenotype, etal.

Secondary Outcome Measures

Name	Time	Method
All adverse events	6 Months	Chills, Fever, Headache, Nausea, Vomiting, Cough, Skin rashes, Anaphylactic shock, Etal.

Trial Locations

Locations (1)

Guangzhou 8th People's Hospital; 🇨🇳 Guangzhou, Guangdong, China