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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02766049
First received: April 1, 2016
Last updated: July 19, 2016
Last verified: May 2016
  Purpose
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 Intervention Phase
HIV Infection
Biological: DC
Biological: DC10e6+HIV-AT2
Biological: DC10e7+HIV-AT2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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:
  • 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

  • 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


Enrollment: 19
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02766049

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

Publications:
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02766049     History of Changes
Other Study ID Numbers: CAPPesq-0239/09
Study First Received: April 1, 2016
Last Updated: July 19, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 25, 2017