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

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

DC10e6+HIV-AT2

DC10e7+HIV-AT2

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, immunotherapy, clinical trial, dendritic cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

(a) DC

(b) DC 10e6+HIV-AT2

Arm Description

Autologous dendritic cells (3x10e7)

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

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

Outcomes

Primary Outcome Measures

Number of participants with ≥ grade 3 adverse events related to product

AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

Secondary Outcome Measures

Number of participants with change in plasma viral load from baseline, over the observation period

Log10 change in HIV RNA

Number of participants with change in CD4+T cells from baseline, over the observation period

Absolute number change of CD4+T cells

Full Information

NCT ID

NCT02766049

First Posted

April 1, 2016

Last Updated

July 19, 2016

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02766049

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

HIV, immunotherapy, clinical trial, dendritic cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

(a) DC

Arm Type

Active Comparator

Arm Description

Autologous dendritic cells (3x10e7)

Arm Title

(b) DC 10e6+HIV-AT2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Intervention Description

Autologous dendritic cells (3x10e7)

Intervention Type

Biological

Intervention Name(s)

DC10e6+HIV-AT2

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

DC10e7+HIV-AT2

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with ≥ grade 3 adverse events related to product

Description

AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

Time Frame

51 weeks

Secondary Outcome Measure Information:

Title

Number of participants with change in plasma viral load from baseline, over the observation period

Description

Log10 change in HIV RNA

Time Frame

Baseline to 51 weeks

Title

Number of participants with change in CD4+T cells from baseline, over the observation period

Description

Absolute number change of CD4+T cells

Time Frame

Baseline to 51 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberto JS Duarte, Professor

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15568033

Citation

Lu W, Arraes LC, Ferreira WT, Andrieu JM. Therapeutic dendritic-cell vaccine for chronic HIV-1 infection. Nat Med. 2004 Dec;10(12):1359-65. doi: 10.1038/nm1147. Epub 2004 Nov 28.

Results Reference

background

PubMed Identifier

20635918

Citation

Oshiro TM, de Almeida A, da Silva Duarte AJ. Dendritic cell immunotherapy for HIV infection: from theory to reality. Immunotherapy. 2009 Nov;1(6):1039-51. doi: 10.2217/imt.09.68.

Results Reference

background

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

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