Clinical trial NCT03240328: The Effect of Chimeric Antigen Receptor (CAR)-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
Official title: The Effect of CAR-T Cell Therapy on the Reconstitution of HIV-specific Immune Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: HIV/AIDS
Keywords: CAR-T HIV therapy
immunotherapy
function cure
Lead sponsor: Guangzhou 8th People's Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2017-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: No control.
Primary purpose: TREATMENT

Brief summary: To study the safety and effectiveness of CAR-T Cell therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, which is expected to enhance the res-constitution of HIV-specific immune function to assist the eradication of HIV reservoir.

Detailed description: Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to curing human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which HIV-1 reservoirs could be eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells.the VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving successful cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. In this clinical trial, we intend to study the safety and effectiveness of CAR-T Cell Therapy on HIV patients whose plasma HIV has been successfully suppressed after cART, by observing the adverse events, HIV-1 reservoir and the immune index.

Eligibility criteria: Inclusion Criteria:

1. HIV infection confirmed.
2. Receiving cART more than 12 months.
3. HIV viral-load \< 50 copies/ml and CD4 cell count more than 350 cells/ul.
4. Without serious liver, heart, liver and kidney diseases.
5. The subjects know about the study and volunteer to attend the research and sign the informed consent.

Exclusion Criteria:

1. With active HBV or HCV infection, or serious opportunistic infections.
2. With serious chronic disease such like diabetes, the mental illness,et al
3. History of suffering from pancreatitis during cART.
4. Pregnant or breast-fed.
5. With poor adherence.
6. Unable to complete follow up.

Primary outcomes:
measure: Incidence of treatment-associated adverse events of CAR-T cell therapy
timeFrame: 6 Months
Secondary outcomes:
measure: HIV-1 reservoir
timeFrame: 6 Months
measure: HIV viral load rebound time
timeFrame: 6 months
Other outcomes:
measure: HIV-specific immunity
timeFrame: 6 Months
Locations:
city: Guangzhou
country: China
facility: Guangzhou 8th People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou 8th People's Hospital
name: Cai Weiping, Bachelor
role: PRINCIPAL_INVESTIGATOR
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