Reconstitution of HIV-specific Immunity Against HIV

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02563509

Enrollment

Registered

2015-09-30

Start date

2016-01-31

Completion date

2017-12-31

Last updated

2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, cellular immunity therapy, functional cure

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.

Interventions

BIOLOGICALHIV-specific CD8 cells

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026