NCT02766049

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
Last Updated

July 20, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

April 1, 2016

Last Update Submit

July 19, 2016

Conditions

HIV Infection

Keywords

HIVimmunotherapyclinical trialdendritic cell

Outcome Measures

Primary Outcomes (1)

  • 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

    51 weeks

Secondary Outcomes (2)

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

    Baseline to 51 weeks

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

    Baseline to 51 weeks

Study Arms (3)

(a) DC

ACTIVE COMPARATOR

Autologous dendritic cells (3x10e7)

Biological: DC

(b) DC 10e6+HIV-AT2

ACTIVE COMPARATOR

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

Biological: DC10e6+HIV-AT2

(c) DC 10e7+HIV-AT2

ACTIVE COMPARATOR

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

Biological: DC10e7+HIV-AT2

Interventions

DCBIOLOGICAL

Autologous dendritic cells (3x10e7)

(a) DC
DC10e6+HIV-AT2BIOLOGICAL

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

(b) DC 10e6+HIV-AT2
DC10e7+HIV-AT2BIOLOGICAL

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

(c) DC 10e7+HIV-AT2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 15568033BACKGROUND

  • 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.

    PMID: 20635918BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Alberto JS Duarte, Professor

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

May 9, 2016

Study Start

February 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share