Reconstitution of HIV-specific Immunity Against HIV

Guangzhou Medical University

Status and phase: Completed; Phase 1

Conditions: HIV

Treatments: Biological: HIV-specific CD8 cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02563509

2013ZX10001004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

HIV-specific CD8 cells

Experimental group

Description:

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

Treatment:

Biological: HIV-specific CD8 cells

Regualar therapy

No Intervention group

Description:

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