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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV Infection	Biological: DC; Biological: DC10e6+HIV-AT2; Biological: DC10e7+HIV-AT2	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
Study Start Date :	February 2010
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: (a) DC; Autologous dendritic cells (3x10e7)	Biological: DC; Autologous dendritic cells (3x10e7)
Active Comparator: (b) DC 10e6+HIV-AT2; Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV	Biological: DC10e6+HIV-AT2; Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
Active Comparator: (c) DC 10e7+HIV-AT2; Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV	Biological: DC10e7+HIV-AT2; Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV

Outcome Measures

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Primary Outcome Measures :

1. Number of participants with ≥ grade 3 adverse events related to product [ Time Frame: 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 Outcome Measures :

1. Number of participants with change in plasma viral load from baseline, over the observation period [ Time Frame: Baseline to 51 weeks ]
   Log10 change in HIV RNA
2. Number of participants with change in CD4+T cells from baseline, over the observation period [ Time Frame: Baseline to 51 weeks ]
   Absolute number change of CD4+T cells

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

Principal Investigator:	Alberto JS Duarte, Professor	University of Sao Paulo

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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. Epub 2004 Nov 28.

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. Review.

Responsible Party:	University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:	NCT02766049 History of Changes
Other Study ID Numbers:	CAPPesq-0239/09
First Posted:	May 9, 2016
Last Update Posted:	July 20, 2016
Last Verified:	May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by University of Sao Paulo General Hospital:

HIV; immunotherapy; clinical trial; dendritic cell

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases	Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases