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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02766049
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766049


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Alberto JS Duarte, Professor University of Sao Paulo
More Information
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Publications:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02766049    
Other Study ID Numbers: CAPPesq-0239/09
First Posted: May 9, 2016    Key Record Dates
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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases