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Therapeutic Vaccine Based on aDC1 Dendritic Cells for the Control of Viremia After ATI in HIV Infected Individuals

NCT05786937 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-28

No results posted yet for this study

Summary

The goal of this interventional study is to validate the strategy of adjuvant therapy with dendritic cells in HIV infection in chronically infected individuals. The main questions it aims to answer are related to the safety and tolerance of the intervention and the virological and immunological impact of immunotherapy with aDC1 in HIV-infected individuals. The study will include 30 diagnosed HIV-infected patients, using antiretroviral therapy, who will be immunized with aDC1 or placebo according to the arms of this study: G1) placebo; G2) aDC1immunization; G3) aDC1 immunization with analytical treatment interruption of ART.

Conditions

  • HIV Vaccine

Interventions

BIOLOGICAL

Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides

Alpha-type-1 Polarizing Dendritic Cells (aDC1) unpulsed with HIV peptides

BIOLOGICAL

Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides

Alpha-type-1 Polarizing Dendritic Cells (aDC1) pulsed with HIV peptides

OTHER

Commercial ringer´s lactate solution

Placebo

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Alberto José DS Duarte, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786937 on ClinicalTrials.gov