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Completed

NCT Number: NCT02766049

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

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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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DC

Biological

Autologous dendritic cells (3x10e7)

DC10e6+HIV-AT2

Biological

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

DC10e7+HIV-AT2

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 9, 2016
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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