HIV InfectionsPhase 2iHIVARNA-01NCT02888756
iHIVARNA Clinical Trial in HIV Infected Individuals
A Phase 2 study testing iHIVARNA-01 and TriMix in people with HIV Infections, run by Rob Gruters at 5 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- iHIVARNA-01 and TriMix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 4 Apr 2017to 12 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age;
- Voluntarily signed informed consent;
- Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
- On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
- Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed);
- Current CD4+ cell count ≥ 450 cells/μl;
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- 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);
- If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).
- 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. -
Who cannot join
- Treatment with non-cART regimen prior to cART regimen;
- Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
- Non-subtype B HIV infection;
- Active Hepatitis B virus and/or Hepatitis C virus co-infection;
- History of a CDC class C event (see appendix A);
- Pregnant female (screened with a positive pregnancy test), lactating or intending to become pregnant during the study;
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- Active malignancy ≤ 30 days (extended period on the clinical assessment of the investigator) prior to screening;
- Active infection with fever (38°C or above) ≤ 10 days of screening and/or first vaccination;
- 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;
- 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;
- Usage of any investigational drug ≤ 90 days prior to study entry;
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Clinic
Barcelona
About this study
Official title: A Phase IIa Randomized, Placebo Controlled, Double Blinded Study to Evaluate the Safety and Immunogenicity of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy
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.
Read the detailed description
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
- HIV Infections
- Being tested
- iHIVARNA-01, TriMix, Placebo
- Keywords
- Immunotherapy, mRNA, Lentivirus infection, Virus disease, Sexually transmitted disease, Immunodeficiency syndrome
- Medical subject headings
- HIV Infections, Lentivirus Infections, Virus Diseases, Sexually Transmitted Diseases, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iHIVARNA-01Biological
Also called HIVACAT, TriMix
Therapeutic vaccination, followed by treatment interruption
TriMixBiological
Therapeutic vaccination, followed by treatment interruption
PlaceboBiological
Therapeutic vaccination, followed by treatment interruption
| Study group | Role | What they receive |
|---|---|---|
| iHIVARNA-01 | Experimental | Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval Receives: Biological: iHIVARNA-01; Biological: TriMix |
| TriMix | Active comparator | Biological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval Receives: Biological: TriMix |
| Placebo | Placebo comparator | Water for injection 3 vaccinations, two weeks interval Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
- Grade 3 or above local adverse event (pain, cutaneous reactions including induration).
- Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia).
- Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively.
Any event attributable to vaccination leading to discontinuation of the immunisation regimen.
Measured: week 6
Immunogenicity as Measured by Elispot
Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups
Measured: week 6 and week 18
Secondary outcomes (10)
Immunogenicity as Measured by Intracellular Cytokine Staining (ICS)
HIV-specific CD4+ and CD8+ T cell responses after immunization by the number of poly-functional T cells as determined by intracellular cytokine staining, (ICS).
Measured: week 10, 18 and 30
Time to Viral Rebound
time until viral rebound (defined as two consecutive measurements of plasma viral load > 1000 copies/mL separated by at least 15 days) after discontinuation at week 6.
Measured: week 6-18
Change in Plasma Viral Load
difference in log10 copies/ml plasma viral load in vivo after analytical treatment interruption (ATI, week 6-restart ART), compared to placebo WFI
Measured: week 6-18
Functional Cure
proportion of patients with viral load below detectable level of 50 copies/mL in plasma after ATI, week 18
Measured: week 18
Primary Immune Response Against Vaccine
Change in frequency of at least 0.7log10 HIV-specific T-cell responses between baseline and week 6
Measured: from baseline to week 6
CD8 T Cell Mediated Viral Suppression
The capacity of CD8 T cells to suppress virus production in HIV infected autologous CD4 T cells, after vaccination. For this purpose PBMC are isolated and separated in CD8 and CD4 T cells. CD4 cells are infected with HIV. Thereafter CD4 cells are co-cultured with pre-stimulated CD8 cells and the capacity to suppress virus production at different effector to target (E:T) ratios is measured, by the change of p24 Gag production. Pannus et al AIDS 2019, PMID: 30702513
Measured: week 4
Proviral DNA Reservoir
effect on reservoir as measured by changes in the proviral DNA copy numbers per million cells during and after immunization
Measured: day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30)
Viral Immune Escape
viral immune escape: change in % mutated epitopes from pre-cART to post-ATI
Measured: week 18
Transcriptomics
host protein mRNA expression profiles in whole blood
Measured: week 6 and 18
Cell-associated RNA Viral Reservoir
effect on reservoir as measured by changes in the intracellular viral RNA copy numbers per million cells during and after immunization
Measured: day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start4 Apr 2017
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Why it stopped: Interim analysis did not show sufficient immunogenicity of IMP compared to placebo
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Gruters
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, IrsiCaixa, Institute of Tropical Medicine, Belgium, Vrije Universiteit Brussel, Synapse bv, Asphalion, eTheRNA immunotherapies, CR2O, Hospital Clinic of Barcelona, Germans Trias i Pujol Hospital, Universitair Ziekenhuis Brussel
- Responsible party
- Sponsor-investigator, Rob Gruters, Erasmus Medical Center
- Investigators
- Rob A Gruters, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888756
- Sponsor's protocol ID
- iHIVARNA phase II
- Other IDs
- 2016-002724-83, 2016
- Acronym
- iHIVARNA-01
- Status last verified
- Dec 2019
- First submitted
- 23 Aug 2016
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31208472
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomized, Placebo Controlled, Double Blinded Study to Evaluate the Safety and Immunogenicity of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT02888756
- Acronym / sponsor ID
- iHIVARNA-01 / iHIVARNA phase II
- Conditions
- HIV Infections
- Keywords
- Immunotherapy, mRNA, Lentivirus infection, Virus disease, Sexually transmitted disease, Immunodeficiency syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis did not show sufficient immunogenicity of IMP compared to placebo
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Rob GrutersUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer, IrsiCaixa, Institute of Tropical Medicine, Belgium, Vrije Universiteit Brussel, Synapse bv, Asphalion, eTheRNA immunotherapies, CR2O, Hospital Clinic of Barcelona, Germans Trias i Pujol Hospital, Universitair Ziekenhuis Brussel
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Posted 9 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iHIVARNA-01 | Experimental | Biological: iHIVARNA-01, Biological: TriMixBiological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA) 3 vaccinations, two weeks interval |
| TriMix | Active comparator | Biological: TriMixBiological: TriMix_300 μg TriMix mRNA 3 vaccinations, two weeks interval |
| Placebo | Placebo comparator | Biological: PlaceboWater for injection 3 vaccinations, two weeks interval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years of age;
- Voluntarily signed informed consent;
- Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
- On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
- Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed);
Key exclusion criteria (12 listed)
- Treatment with non-cART regimen prior to cART regimen;
- Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
- Non-subtype B HIV infection;
- Active Hepatitis B virus and/or Hepatitis C virus co-infection;
- History of a CDC class C event (see appendix A);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iHIVARNA-01Also: HIVACAT, TriMixTherapeutic vaccination, followed by treatment interruption | Biological | iHIVARNA-01 |
| TriMixTherapeutic vaccination, followed by treatment interruption | Biological | TriMix, iHIVARNA-01 |
| PlaceboTherapeutic vaccination, followed by treatment interruption | Biological | Placebo |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: week 6
* Grade 3 or above local adverse event (pain, cutaneous reactions including induration). * Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia). * Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively. Any event attributable to vaccination leading to discontinuation of the immunisation regimen.
Immunogenicity as Measured by Elispot
Time frame: week 6 and week 18
Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups
10 secondary outcomes
Immunogenicity as Measured by Intracellular Cytokine Staining (ICS)
Time frame: week 10, 18 and 30
Time to Viral Rebound
Time frame: week 6-18
Change in Plasma Viral Load
Time frame: week 6-18
Functional Cure
Time frame: week 18
Primary Immune Response Against Vaccine
Time frame: from baseline to week 6
CD8 T Cell Mediated Viral Suppression
Time frame: week 4
Proviral DNA Reservoir
Time frame: day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30)
Viral Immune Escape
Time frame: week 18
Transcriptomics
Time frame: week 6 and 18
Cell-associated RNA Viral Reservoir
Time frame: day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31208472de 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.
- Description phase 1 clinical trial with iHIVARNA-01Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob A Gruters, PhD principal investigator
Erasmus Medical Center
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iHIVARNA-01 and TriMix in people with HIV Infections, run by Rob Gruters at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.