Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: HIV Infection

Treatments: Biological: DC; Biological: DC10e6+HIV-AT2; Biological: DC10e7+HIV-AT2

Study type: Interventional

Funder types: Other

Identifiers

NCT02766049

CAPPesq-0239/09

Details and patient eligibility

About

The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with HIV infection;
• absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
• plasma viral load ≥ 1,000 copies / mL, stable (ie no variation > 0.5 log) in the six months before the start of the study;
• blood CD4+ T cells ≥ 350 /mL, stable (ie no variation > 25%) in the six months before the start of the study.

Exclusion criteria

• individuals without proper venous access for blood and apheresis collection procedure.
• use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
• history of diagnosis of HIV infection <01 years;
• pregnancy or breast-feeding;
• use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
• presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

(a) DC

Active Comparator group

Description:

Autologous dendritic cells (3x10e7)

Treatment:

Biological: DC

(b) DC 10e6+HIV-AT2

Active Comparator group

Description:

Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV

Treatment:

Biological: DC10e6+HIV-AT2

(c) DC 10e7+HIV-AT2

Active Comparator group

Description:

Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV

Treatment:

Biological: DC10e7+HIV-AT2