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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02766049

Enrollment

Registered

2016-05-09

Start date

2010-02-28

Completion date

2014-05-31

Last updated

2016-07-20

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

Conditions

HIV Infection

Keywords

HIV, immunotherapy, clinical trial, dendritic cell

Brief summary

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.

Interventions

BIOLOGICALDC

Autologous dendritic cells (3x10e7)

BIOLOGICALDC10e6+HIV-AT2

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

BIOLOGICALDC10e7+HIV-AT2

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with ≥ grade 3 adverse events related to product	51 weeks	AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

Secondary

Measure	Time frame	Description
Number of participants with change in plasma viral load from baseline, over the observation period	Baseline to 51 weeks	Log10 change in HIV RNA
Number of participants with change in CD4+T cells from baseline, over the observation period	Baseline to 51 weeks	Absolute number change of CD4+T cells

Outcome results

None listed

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