iHIVARNA Clinical Trial in HIV Infected Individuals

Summary

iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture of APC activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and the HIV target antigens contained in HIVACAT to be administered through the intranodal route. iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling viral replication in the absence of anti-retroviral therapy.

Conditions

• HIV Infections

Interventions

BIOLOGICAL

iHIVARNA-01

Therapeutic vaccination, followed by treatment interruption

BIOLOGICAL

TriMix

Therapeutic vaccination, followed by treatment interruption

BIOLOGICAL

Placebo

Therapeutic vaccination, followed by treatment interruption

Sponsors & Collaborators

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  collaborator OTHER

• IrsiCaixa

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• Synapse bv

  collaborator INDUSTRY

• Asphalion

  collaborator UNKNOWN

• eTheRNA immunotherapies

  collaborator INDUSTRY

• CR2O

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Rob Gruters

  lead OTHER

Principal Investigators

• Rob A Gruters, PhD · Erasmus Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-04

Primary Completion

2018-02-12

Completion

2018-02-12

Countries

• Belgium
• Netherlands
• Spain

Study Locations