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iHIVARNA Clinical Trial in HIV Infected Individuals

NCT ID: NCT02888756

Last Updated: 2019-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2018-02-12

Brief Summary

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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.

Detailed Description

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Objective: To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic vaccine in HIV infected patients.

Study design and duration: Phase IIa, multicentre double-blind placebo controlled intervention study. Each patient will be followed for 30 weeks. The study duration will be 38 weeks from inclusion of the first patient.

Sites: Erasmus MC, Rotterdam The Netherlands (sponsor), Hospital Clínic de Barcelona and Institut de Recerca de la Sida - Caixa, Barcelona, Spain, Instituut voor Tropische Geneeskunde Antwerp, Belgium and Vrije Universiteit Brussel/UZ Brussel, Belgium

Study population: Chronically HIV-1- infected patients under stable cART with plasma viral load (pVL) ≤ 50 copies/ml and stable CD4+ T-cell counts ≥ 450/μl, aged 18 years or above.

Sample size: after recruitment and screening, 70 patients will be included and randomized to one of the study-arms.

Intervention: One group (n=40) receives the HIVACAT-TriMix (300 microgram TriMix + 900 microgram HIVACAT) vaccine intranodally on three occasions with a two-week interval. One control group (n=15) receives TriMix only (300 microgram TriMix) and one group (n=15) receives saline intranodally on three occasions with a two-week interval. Two weeks after the last vaccination cART treatment will be interrupted. If plasma virus is detectable, cART will be re-initiated twelve weeks after treatment interruption. cART can always be re-initiated for medical reasons, as judged by the clinical investigator.

Conditions

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HIV Infections

Keywords

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Immunotherapy mRNA Lentivirus infection Virus disease Sexually transmitted disease Immunodeficiency syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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iHIVARNA-01

Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval

Group Type EXPERIMENTAL

iHIVARNA-01

Intervention Type BIOLOGICAL

Therapeutic vaccination, followed by treatment interruption

TriMix

Intervention Type BIOLOGICAL

Therapeutic vaccination, followed by treatment interruption

TriMix

Biological: TriMix\_300 μg TriMix mRNA 3 vaccinations, two weeks interval

Group Type ACTIVE_COMPARATOR

TriMix

Intervention Type BIOLOGICAL

Therapeutic vaccination, followed by treatment interruption

Placebo

Water for injection 3 vaccinations, two weeks interval

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Therapeutic vaccination, followed by treatment interruption

Interventions

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iHIVARNA-01

Therapeutic vaccination, followed by treatment interruption

Intervention Type BIOLOGICAL

TriMix

Therapeutic vaccination, followed by treatment interruption

Intervention Type BIOLOGICAL

Placebo

Therapeutic vaccination, followed by treatment interruption

Intervention Type BIOLOGICAL

Other Intervention Names

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HIVACAT TriMix

Eligibility Criteria

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Inclusion Criteria

1. ≥ 18 years of age;
2. Voluntarily signed informed consent;
3. Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
4. On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
5. Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed);
6. Current CD4+ cell count ≥ 450 cells/μl;
7. HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called 'blips' ≤ 500 copies/mL are permitted);
8. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).

1. For heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; consistent record with condoms; physiological or anatomical sterility (in self or partner) from 14 days prior to the first vaccination until 4 months after the last vaccination.

For heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination. -

Exclusion Criteria

1. Treatment with non-cART regimen prior to cART regimen;
2. Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
3. Non-subtype B HIV infection;
4. Active Hepatitis B virus and/or Hepatitis C virus co-infection;
5. History of a CDC class C event (see appendix A);
6. Pregnant female (screened with a positive pregnancy test), lactating or intending to become pregnant during the study;
7. Active malignancy ≤ 30 days (extended period on the clinical assessment of the investigator) prior to screening;
8. Active infection with fever (38°C or above) ≤ 10 days of screening and/or first vaccination;
9. Therapy with immunomodulatory agents (e.g. systemic corticosteroids), including cytokines (e.g. IL-2), immunoglobulins and/or cytostatic chemotherapy ≤ 90 days prior to screening. This does not include seasonal influenza, hepatitis B and/or other travel related vaccines;
10. Congenital, acquired or induced coagulation disorders, such as thrombocytopenia (thrombocytes \< 150x109/L) and/or current use of anti-coagulant medication (e.g. coumarins, inhibitors of Xa); Usage of NSAIDs (including acetylsalicylic acid) is allowed, however it is advised to interrupt therapy 10 days ahead of vaccination;
11. Usage of any investigational drug ≤ 90 days prior to study entry;
12. An employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator Any other condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role collaborator

IrsiCaixa

OTHER

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

Synapse bv

INDUSTRY

Sponsor Role collaborator

Asphalion

UNKNOWN

Sponsor Role collaborator

eTheRNA immunotherapies

INDUSTRY

Sponsor Role collaborator

CR2O

UNKNOWN

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role collaborator

Rob Gruters

OTHER

Sponsor Role lead

Responsible Party

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Rob Gruters

Workgroup leader

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rob A Gruters, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Institute for Tropical Medicine

Antwerp, , Belgium

Site Status

UZ Brussel

Brussels, , Belgium

Site Status

Erasmus MC

Rotterdam, , Netherlands

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Belgium Netherlands Spain

References

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de Jong W, Aerts J, Allard S, Brander C, Buyze J, Florence E, van Gorp E, Vanham G, Leal L, Mothe B, Thielemans K, Plana M, Garcia F, Gruters R; iHIVARNA consortium. iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy. Trials. 2019 Jun 17;20(1):361. doi: 10.1186/s13063-019-3409-1.

Reference Type DERIVED
PMID: 31208472 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.gov/ct2/show/NCT02413645

Description phase 1 clinical trial with iHIVARNA-01

Other Identifiers

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2016-002724-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

iHIVARNA phase II

Identifier Type: -

Identifier Source: org_study_id