HIV-infectionPhase 1NCT02413645

Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients

A Phase 1 study testing TriMix_100, TriMix_300 and 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) in people with HIV-infection, run by Judit Pich Martínez at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-infection
What is being tested?: TriMix_100, TriMix_300 and 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteSpain
Study dates: Jun 2015to Oct 2016
Phase: Phase 1
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

Patient is ≥ 18 years of age
Voluntarily signed informed consent
Patient is male, or female with negative pregnancy test prior to enrolment
Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA before cART)
Patient must be on stable treatment with cART for at least 6 months (cART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents)
Nadir CD4+ cell counts must be above or equal to 350 cells/μl (1 or 2 occasional determinations below 350 will be allowed)
Current CD4+ cell count must be at least 450 cells/μl
HIV-RNA must be below 50 copies/ mL for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/mL are permitted)

Who cannot join

Treatment with a non-cART regimen of antiretroviral agents prior to the start of cART;
History of a CDC class C event (see Appendix V);
Patient is female and has a positive pregnancy test or the wish of pregnancy:
Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
Use of anti-coagulant medication;

Show all 11Show fewer

Use of any investigational drug during the 90 days prior to study entry;
Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy EudraCT No. 2014-004591-32 33 Protocol version 1.1, dated 10 February 2015
Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
Active hepatitis C virus or hepatitis B virus co-infection
Non-subtype B HIV infection

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínic de Bacelona
Barcelona, 08036

Other trials in Spain

About this study

Official title: A Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy

The main purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV

Conditions: HIV-infection
Being tested: TriMix_100, TriMix_300, 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA), 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA), 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TriMix_100Biological
100 μg of TriMix in
TriMix_300Biological
300 μg of TriMix in
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)Biological
Also called iHIVARNA-01.1
600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT)
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)Biological
Also called iHIVARNA-01.2
900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT)
1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)Biological
Also called iHIVARNA-01.3
1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT)

Study groups in NCT02413645
Study group	Role	What they receive
100 μg TriMix mRNA (TriMix_100)	Other	Cohort 1 (control group) 3 patients will receive 100 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a dose limiting toxicity (DLT), DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). Receives: Biological: TriMix_100
300 μg TriMix mRNA (TriMix_300)	Other	Cohort 2 (control group) 3 patients will receive 300 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). Receives: Biological: TriMix_300
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)	Experimental	Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). Receives: Biological: 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)	Experimental	Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). Receives: Biological: 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)
1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA)	Experimental	Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4). Receives: Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicity (DLT)
Safety as measured by dose limiting toxicity (DLT), defined as:
- 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 24

Secondary outcomes (3)

Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against IN Peptide Pools as Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24.
Changes in the magnitude of total HIV-1-specific immune response against IN peptide pools as measured by ELISPOT at baseline and weeks 4, 6, 8 and 24 Results were considered positive if the number of SFC/106 cells in stimulated wells was two-fold higher than that in unstimulated control wells, and if there were at least 50 SFC/106 cells after background subtraction.
Measured: weeks 4, 6, 8 and 24
Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against OUT Peptide Pools as Measured by ELISPOT at Abseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24.
Changes in the magnitude of total HIV-1-specific immune response against OUT peptide pools as measured by ELISPOT at abseline and weeks 4, 6, 8 and 24.
Results were considered positive if the number of SFC/106 cells in stimulated wells was two-fold higher than that in unstimulated control wells, and if there were at least 50 SFC/106 cells after background subtraction.
Measured: weeks 4, 6, 8 and 24
Secondary End Point: Effect on Reservoir
Changes from baseline in the intracelullar viral RNA copy number per million cells during and after the immunzation at week 4, 6, 8 and 24
Measured: weeks 4, 6, 8 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Oct 2016

First posted10 Apr 2015 (estimated)
Study startJun 2015
Primary completionJun 2016
Study completionOct 2016

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-infectionStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02413645
Sponsor's protocol ID: iHIVARNA
Other IDs: 2014-004591-32, 2014
Status last verified: Aug 2025
First submitted: 30 Mar 2015
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Leal L, Guardo AC, Moron-Lopez S, Salgado M, Mothe B, Heirman C, Pannus P, Vanham G, van den Ham HJ, Gruters R, Andeweg A, Van Meirvenne S, Pich J, Arnaiz JA, Gatell JM, Brander C, Thielemans K, Martinez-Picado J, Plana M, Garcia F; iHIVARNA consortium. Phase I clinical trial of an intranodally administered mRNA-based therapeutic vaccine against HIV-1 infection. AIDS. 2018 Nov 13;32(17):2533-2545. doi: 10.1097/QAD.0000000000002026.
PubMed 30289805

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy
ClinicalTrials.gov ID: NCT02413645
Acronym / sponsor ID: iHIVARNA
Conditions: HIV-infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Judit Pich MartínezUniversity, hospital or other
Study start: Jun 2015 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 10 Apr 2015 (estimated)
Results: Posted 22 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
100 μg TriMix mRNA (TriMix_100)	Other	Biological: TriMix_100Cohort 1 (control group) 3 patients will receive 100 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a dose limiting toxicity (DLT), DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4).
300 μg TriMix mRNA (TriMix_300)	Other	Biological: TriMix_300Cohort 2 (control group) 3 patients will receive 300 μg of mRNA (i.e. 100 μg TriMix mRNA).If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4).
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)	Experimental	Biological: 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)Cohort 3 (experimental group) 3 patients will receive 600 μg of mRNA (300 μg HIV mRNA + 300 μg TriMix mRNA). If two or more of the three patients have a DLT, DSMB should be consulted and study will be terminated. If one or no patients have a dose limiting toxicity, three patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4).
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)	Experimental	Biological: 900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)Cohort 4 (experimental group) 3 patients will receive 900 μg of mRNA (i.e. 600 μg HIV mRNA and 300 μg TriMix mRNA). If two or more of the three first patients have a DLT, then additional three patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients have a DLT, additional three patients will be enrolled at 900 μg dose level. If two or more of the six patients receiving 900 μg of mRNA have a DLT, then additional 3 patients will be enrolled at the previous level dose (dose will be reduced to 600 μg of mRNA per vaccination). If one or no patients of the six patients have a DLT, six patients will be enrolled at the next dose level. Each patient will receive 3 immunizations (at weeks 0, 2 and 4).
1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA)	Experimental	Biological: 1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)Cohort 5 (experimental group) 6 patients will receive 1200 μg of mRNA (i.e. 900 μg HIV mRNA + 300 μg TriMix mRNA) in case one or no patients of the six patients at the previous dose level have a DLT. Each patient will receive 3 immunizations (at weeks 0, 2 and 4).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient is ≥ 18 years of age
Voluntarily signed informed consent
Patient is male, or female with negative pregnancy test prior to enrolment
Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA before cART)
Patient must be on stable treatment with cART for at least 6 months (cART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents)

Key exclusion criteria (11 listed)

Treatment with a non-cART regimen of antiretroviral agents prior to the start of cART;
History of a CDC class C event (see Appendix V);
Patient is female and has a positive pregnancy test or the wish of pregnancy:
Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;

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
TriMix_100100 μg of TriMix in	Biological	100 μg TriMix mRNA (TriMix_100)
TriMix_300300 μg of TriMix in	Biological	300 μg TriMix mRNA (TriMix_300)
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)Also: iHIVARNA-01.1600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT)	Biological	600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)Also: iHIVARNA-01.2900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT)	Biological	900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)
1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)Also: iHIVARNA-01.31200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT)	Biological	1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA)

Primary outcome

Dose Limiting Toxicity (DLT)
Time frame: week 24
Safety as measured by dose limiting toxicity (DLT), defined as: * 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

3 secondary outcomes

Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against IN Peptide Pools as Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24.
Time frame: weeks 4, 6, 8 and 24
Secondary Endpoint: Immunogenicty - Changes in the Magnitude of Total HIV-1-specific Immune Response Against OUT Peptide Pools as Measured by ELISPOT at Abseline and Weeks 4, 6, 8 and 24 Measured by ELISPOT at Baseline and Weeks 4, 6, 8 and 24.
Time frame: weeks 4, 6, 8 and 24
Secondary End Point: Effect on Reservoir
Time frame: weeks 4, 6, 8 and 24

Results and safety

Results posted to the registry on 22 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
100 μg TriMix mRNA (TriMix_100)	3	3
300 μg TriMix mRNA (TriMix_300)	3	3
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)	3	3
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)	6	6
1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA)	6	6

Primary outcome: Dose Limiting Toxicity (DLT)

Time frame: week 24. Number. Unit: participants

Measure	100 μg TriMix mRNA (TriMix_100) n = 3	300 μg TriMix mRNA (TriMix_300) n = 3	600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) n = 3	900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA) n = 3	1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA) n = 6
Value	0	0	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
100 μg TriMix mRNA (TriMix_100)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
300 μg TriMix mRNA (TriMix_300)	0 of 3 (0%)	3 of 3 (100%)	0 of 3
600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
1200μg mRNA(900 μg HIV mRNA+300 μg TriMix mRNA)	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Limitations and caveats (from the sponsor): There was an error in the study product, see: https://insights.ovid.com/pubmed?pmid=31490219

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30289805Leal L, Guardo AC, Moron-Lopez S, Salgado M, Mothe B, Heirman C, Pannus P, Vanham G, van den Ham HJ, Gruters R, Andeweg A, Van Meirvenne S, Pich J, Arnaiz JA, Gatell JM, Brander C, Thielemans K, Martinez-Picado J, Plana M, Garcia F; iHIVARNA consortium. Phase I clinical trial of an intranodally administered mRNA-based therapeutic vaccine against HIV-1 infection. AIDS. 2018 Nov 13;32(17):2533-2545. doi: 10.1097/QAD.0000000000002026.

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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.

Felipe García principal investigator

Hospital Clinic of Barcelona

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TriMix_100, TriMix_300 and 600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA) in people with HIV-infection, run by Judit Pich Martínez at 1 site in Spain.

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 8 inclusion and 11 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 22 Aug 2025). 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?

Dose Limiting Toxicity (DLT) (time frame: week 24). 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 NCT02413645, 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 22 Aug 2025.