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COMPLETEDPHASE1

Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients

Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated HIV in HIV-1 Infected Patients. Prospective, Randomized, Partially Blinded Study

NCT02767193•Judit Pich Martínez

View on ClinicalTrials.gov

Summary

single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective, placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with pegylated interferon.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient \> 18 years of age;
•2. Voluntarily sign informed consent;
•3. Men or women with a negative pregnancy test before inclusion in the study;
•4. HIV infection tested (with positive antibodies to HIV-1 and a detectable viral load);
•5. Patient must be on stable treatment with cART at least 1 year
•6. The average of all measurements of CD4 during the year before starting cART should be equal or greater than 350 cells / mm3
•7. The number of CD4 + at enrollment must be equal or greater than 450 cells / mm3;
•8. Plasma HIV viral load undetectable at least 6 months before the inclusion in the study, at least two determinations (occasional blips above the undetectable level are allowed).

Exclusion Criteria

•1. Treatment with suboptimal regimen (less than 3 antiretroviral drugs) before starting cART;
•2. History of C CDC events;
•3. Interruption of cART during the inclusion in the study;
•4. Pregnancy woman or becoming pregnant in the next months;
•5. Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
•6. Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gamma globulins or chemotherapy within 90 days prior to the screening visit;
•7. Use of anticoagulant medication;
•8. Use of any investigational drug within 90 days prior to study entry;
•9. Virological failure prior to antiretroviral treatment and / or mutations that confer resistance to antiretroviral drugs;
•10. Uncontrolled psychiatric disorder;
+7 more criteria

Locations (1)

Hospital Clínic

Barcelona, España, Spain

Key Dates

Start Date

May 1, 2016

Primary Completion Date

May 22, 2019

Completion Date

May 22, 2019

Last Updated

July 26, 2019

Enrollment

ACTUAL participants

Conditions

HIV Infection

Interventions

DCV3

BIOLOGICAL

DCV3 with PEG-INF

BIOLOGICAL

Placebo

BIOLOGICAL

Placebo with PEG-INF

BIOLOGICAL

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients

Inclusion Criteria

Exclusion Criteria

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