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

U

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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