NCT02767193

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

April 22, 2016

Last Update Submit

July 25, 2019

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with adverse events of grade 3 or higher

    * Local adverse events of grade 3 or higher (pain and skin reactions including induration) * Systemic adverse events of grade 3 or higher (fever, chills, headache, nausea, vomiting, malaise and myalgia) * Clinical or laboratory confirmed grade 3 or higher on physical examination or retests adverse events Any event attributable to the vaccine involving a discontinuation of vaccination regime.

    28 weeks

  • Virological

    Proportion of patients with undetectable viral load (\<37 copies / mL) at 12 weeks

    12 weeks

Secondary Outcomes (10)

  • Number of adverse events grade 1 and 2 within 14 days after each immunization (weeks 2, 4 and 6)

    6 weeks

  • Changes in the specific immune response

    28 weeks

  • Changes in levels of viral reservoir.

    28 weeks

  • Proportion of patients with changes in any value of the levels of inflammatory markers, microbial translocation and immune activation

    28 weeks

  • Proportion of patients with viral rebound

    15 days

  • +5 more secondary outcomes

Study Arms (4)

DCV3

EXPERIMENTAL

Autologus differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus

Biological: DCV3

DCV3 with PEG-INF

EXPERIMENTAL

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG-INF

Biological: DCV3 with PEG-INF

CD placebo

PLACEBO COMPARATOR

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded

Biological: Placebo

CD placebo + PEG-INF

PLACEBO COMPARATOR

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG-INF

Biological: Placebo with PEG-INF

Interventions

DCV3BIOLOGICAL

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus. Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4

DCV3
DCV3 with PEG-INFBIOLOGICAL

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG\_INF Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4 and INF during weeks 4,5 and 6

DCV3 with PEG-INF
PlaceboBIOLOGICAL

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4

CD placebo
Placebo with PEG-INFBIOLOGICAL

Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG\_INF Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4 and INF during weeks 4,5 and 6.

CD placebo + PEG-INF

Eligibility Criteria

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

You may qualify if:

  • Patient \> 18 years of age;
  • Voluntarily sign informed consent;
  • HIV infection tested (with positive antibodies to HIV-1 and a detectable viral load);
  • Patient must be on stable treatment with cART at least 1 year
  • The average of all measurements of CD4 during the year before starting cART should be equal or greater than 350 cells / mm3
  • The number of CD4 + at enrollment must be equal or greater than 450 cells / mm3;

You may not qualify if:

  • Treatment with suboptimal regimen (less than 3 antiretroviral drugs) before starting cART;
  • History of C CDC events;
  • Pregnancy woman or becoming pregnant in the next months;
  • Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
  • Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gamma globulins or chemotherapy within 90 days prior to the screening visit;
  • Use of anticoagulant medication;
  • Use of any investigational drug within 90 days prior to study entry;
  • Virological failure prior to antiretroviral treatment and / or mutations that confer resistance to antiretroviral drugs;
  • Uncontrolled psychiatric disorder;
  • Platelet count \<80,000 / mm3;
  • Values ??of hemoglobin \<12g / dL;
  • Patients with active uncontrolled autoimmune diseases;
  • Using contraindicated drugs in accordance with the Summary of Product Specifications of pegylated interferon;
  • Childbearing, or potential childbearing not using highly effective contraception;
  • Any other problem that according to the investigator could interfere with the evaluation of the objectives.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, España, 08036, Spain

Location

Related Publications (1)

  • Leal L, Couto E, Sanchez-Palomino S, Climent N, Fernandez I, Miralles L, Romero Y, Gonzalez T, Maleno MJ, Pano B, Pich J, Nicolau C, Gatell JM, Plana M, Garcia F; DCV3-RISVAC04 Study Group. Effect of Intranodally Administered Dendritic Cell-Based HIV Vaccine in Combination With Pegylated Interferon alpha-2a on Viral Control Following ART Discontinuation: A Phase 2A Randomized Clinical Trial. Front Immunol. 2021 Nov 11;12:767370. doi: 10.3389/fimmu.2021.767370. eCollection 2021.

    PMID: 34858423DERIVED

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 Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 10, 2016

Study Start

May 1, 2016

Primary Completion

May 22, 2019

Study Completion

May 22, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations

ES(1)