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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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(a) DC

Autologous dendritic cells (3x10e7)

Group Type ACTIVE_COMPARATOR

DC

Intervention Type BIOLOGICAL

Autologous dendritic cells (3x10e7)

(b) DC 10e6+HIV-AT2

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

Group Type ACTIVE_COMPARATOR

DC10e6+HIV-AT2

Intervention Type BIOLOGICAL

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

(c) DC 10e7+HIV-AT2

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

Group Type ACTIVE_COMPARATOR

DC10e7+HIV-AT2

Intervention Type BIOLOGICAL

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

Interventions

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DC

Autologous dendritic cells (3x10e7)

Intervention Type BIOLOGICAL

DC10e6+HIV-AT2

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

Intervention Type BIOLOGICAL

DC10e7+HIV-AT2

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No