HIV InfectionPhase 1NCT01433289
Study to Evaluate Safety and Toxicity of Polyphenon E (EGCG) in HIV-1-Infected Individuals
A Phase 1 study testing Polyphenon E in people with HIV Infection, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and treatment-experienced adults not on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Polyphenon E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Jul 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected individual as having at least two of the following in any combination obtained from 2 different samples: Positive HIV rapid test or ELISA and Western Blot; HIV RNA PCR>10,000 copies/ml; positive HIV DNA PCR; neutralizable HIV p 24 antigen
- Asymptomatic HIV-1 infected individuals who are either antiretroviral-naive or treatment-experienced. Subjects must have not been on ARV treatment for at least 12 weeks prior to enrollment and not have plans to start ARV treatment within 8 weeks of study initiation.
- Male or female 18 to 65 years of age. Males must use barrier methods of contraception Females must be willing to abide by protocol specified methods to avoid becoming pregnant. Women of childbearing potential must use an adequate form of birth control determined by the investigator (e.g., oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or vasectomy).
- HIV-1 RNA >1,000 copies/mL at Screening.
- In the opinion of the investigator, subject has a stable CD4+ T lymphocyte count while off ARV and 250 cells/mm3 at Screening.
- Participants should have no clinically significant findings on screening evaluations (clinical, laboratory, or EKG).
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- Be able to comprehend and willing to sign an ICF.
- Be able to comply with the protocol requirements.
- Have life expectancy > 6 months.
- Laboratory values obtained during screening must be within normal limits or meet the following requirements (Safety Labs):
- ANC 1000/mm3
- Hemoglobin 9.0 g/dL
- Glucose (nonfasting) <116 mg/dL
- Bilirubin 1.5 x upper limit of normal (ULN)
- Liver function tests (AST \& ALT) 1.25 x ULN at screening and baseline
- GGT < 5.0 x ULN
- Negative hepatitis panel obtained less than or equal to 6 months prior to Study Entry
- Creatinine 1.3 x ULN
- Creatine phosphokinase (CPK) 5 x ULN unless further evaluation determines it to be due to exercise
- Urine protein 2+
- Prothrombin time (PT)1.25 x ULN
- Lipase 1.2 x ULN
Who cannot join
- Current or recent (<3 months) history of opportunistic infection that,
- Acute illness within 1 week of the baseline visit.
- Participant is not able to comply with the dosing schedule and protocol evaluations.
- Participant is anticipated to begin ARV treatment during participation in the study.
- Pregnancy, breastfeeding or postpartum (less than 3 months).
- Diagnosis of diabetes.
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- Any condition which could compromise participant safety or adherence to the protocol.
- Documented positive test for hepatitis B surface antigen, hepatitis B surface antibody (with the exception of participants who received hepatitis B vaccination and have hepatitis B surface antibody), hepatitis B core antibody, and hepatitis C antibody.
- Any grade 3 or 4 laboratory abnormality noted at screening according to the DAIDS grading scale (Appendix A), except for the following:
- Grade 3 or 4 triglyceride elevations.
- Grade 3 cholesterol elevation.
- Grade 3 non-fasting glucose elevation.
- Participant has a malabsorption syndrome possibly affecting drug absorption (e.g. Crohn's disease or chronic pancreatitis).
- Participant has received an HIV prophylactic or therapeutic vaccination within 6 months prior to the first dose of study medication.
- Investigational therapy within 30 days prior to the Baseline visit.
- Radiation therapy or systemic cytotoxic chemotherapeutic agents within 12 weeks prior to the baseline visit or have not recovered from side effects from such therapy prior to the first dose of study medication.
- Positive urine screen for drugs of abuse at Screening, unless the investigator deems that the result is associated with a prescribed medication or inhaled use of THC.
- Inability to avoid all tea/tea products (including herbal, caffeinated, decaffeinated, iced tea), apples, chocolate, broad beans (fava beans), plums, prunes, cherries, fruit juices containing apples, cherries, or plums, dietary supplements, and herbal products for 1 week prior to the baseline visit and for the duration of the study.
- Inability to limit caffeine intake to not exceed 12 oz. of caffeinated beverage per day (if espresso, no more than 1 oz. or 1 shot) beginning 2 days prior and for the duration of the study.
- Prior exposure to TNX-355 (an investigational anti-HIV agent that binds to the CD4+ T lymphocyte surface).
- Participant has used proton pump inhibitors starting 14 days before Study Day 1 and is unable to avoid taking proton pump inhibitors for the duration of the study.
- Participant has used H2 blockers starting 24 hours before Study Day 1 and is unable to avoid taking H2 blockers for the duration of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
University of Texas Health Science Center Houston
Houston, Texas, 77030
About this study
Official title: Placebo-Controlled, Dose-Blinded, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Polyphenon E (EGCG) 14 Day Monotherapy in Antiretroviral Naïve and Experienced, HIV-1-Infected Subjects
The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and treatment-experienced adults not on concomitant antiretroviral (ARV) therapy.
Read the detailed description
HIV-1 infection ultimately results in impaired specific immune function by virtue of the initial binding of the HIV-1 virion envelope glycoprotein 120 (gp120) to the CD4 receptor in complex with a chemokine receptor on the T-cell surface1. Even though gp120 elicits virus-neutralizing antibodies, HIV-1 eludes the immune system and leads to the onset of AIDS. Ever since the discovery of the virus as the causative agent, there has been an intense effort to develop therapeutic methods to inhibit or prevent infection.2-4 CD4, a cell surface glycoprotein expressed on T cells, plays an important role in the recognition of antigens by T cells and in their activation.5 It also acts as a receptor for HIV-1 as gp120 binds to it via its D1 domain and, uses this interaction to infect CD4+ T cells.5 Therefore, there has been interest in finding molecules that block the binding of gp120 to CD4 (entry inhibitors) as a way of reducing HIV-1 infectivity.
Studies have demonstrated evidence of high affinity binding of EGCG to the CD4 molecule with a Kd of 10nM with subsequent inhibition of gp120 binding to human CD4+ T cells. EGCG binds in the same molecular pocket on CD4, as does HIV-1-gp120 at physiologically relevant concentrations.
This is a phase I, placebo-controlled, dose-blinded, randomized study of Polyphenon® E as monotherapy in participants who are HIV-1-infected with a CD+ T lymphocyte count of at least 250 cells/mm3 and are ARV-naïve or ARV-experienced. There will be 3 dose levels and for each dose level, there will be 6 subjects who will receive the study drug and 2 subjects who will be randomized to take placebo. Dosing will be escalated sequentially contingent on the safety profile of previous doses. Safety data from all participants receiving Polyphenon® E in the preceding dose level will be evaluated and considered acceptable prior to escalation to the next higher dose. PK analyses will be also performed as each dose level is completed. If at least 4 subjects on the active drug in each dose level have evaluable PK data, subjects will not be replaced. As the inability to achieve adequate EGCG concentrations that are necessary to inhibit HIV-1 replication is a major concern in this study, it is necessary to confirm EGCG pharmacokinetics in the event that the primary outcome measure of virologic response is not observed for each dose level. For each PK visit on Study Days 1 and 14, a total of 10 blood samples will be obtained per subject. If only a few samples cannot be used (this depends on the individual subject's pharmacokinetic profile, although one or two unevaluable samples will not likely cause a subject's data to be unevaluable), PK analyses can still be performed and will not require subjects to be deemed unevaluable and replaced.
- Conditions
- HIV Infection
- Being tested
- Polyphenon E, Placebo
- Keywords
- HIV, safety, toxicity, pharmacokinetics, Polyphenon E, EGCG, green tea, CD4, viral load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon EDrug
Also called EGCG, epigallocatechin gallate, green tea catechin, green tea extract
There will be 3 dose levels and for each dose level, there will be 6 subjects who will receive the study drug and 2 subjects who will be randomized to take placebo. Dosing will be escalated sequentially contingent on the safety profile of previous doses. Safety data from all participants receiving Polyphenon® E in the preceding dose level will be evaluated and considered acceptable prior to escalation to the next higher dose. PK analyses will be also performed as each dose level is completed. It is necessary to confirm EGCG pharmacokinetics in the event that the primary outcome measure of virologic response is not observed for each arm. For each PK visit on Study Days 1 and 14, a total of 10 blood samples will be obtained per subject.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Polyphenon E 1600 mg/day | Experimental | Drug: Polyphenon E Polyphenon E capsules containing 200 mg of epigallocatechin-gallate. Four capsules twice a day. Receives: Drug: Polyphenon E |
| Polyphenon E 2400 mg/day | Experimental | Drug: Polyphenon E Polyphenon E capsules containing 200 mg of epigallocatechin-gallate. Six capsules twice a day. Receives: Drug: Polyphenon E |
| Polyphenon E 3200 mg/day | Experimental | Drug: Polyphenon E Polyphenon E capsules containing 200 mg of epigallocatechin-gallate. Eight capsules twice a day. Receives: Drug: Polyphenon E |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Safety of Polyphenon E (800mg, 1200mg, 1600mg EGCG twice daily for 14 days) in HIV-1-infected subjects.
Measured: 14 days
Median Change of log10 HIV-1 RNA Copies/ml
Median change of log10 HIV-1 RNA copies/ml from baseline in subjects who have completed 14 days of treatment (800mg, 1200mg, 1600mg EGCG bid) or placebo.
Measured: Baseline and 14 days
Secondary outcomes (3)
Number of Participants Achieving > 0.75 or 1.0 log10 Reduction in HIV-1 RNA or <400 Copies/ml
The number of participants achieving >0.75 or 1.0 log10 reduction in HIV-1 RNA or <400 copies/ml with 14 days of Polyphenon E (800mg, 1200mg, or 1600mg EGCG bid) or placebo.
Measured: Baseline to 14 days
The Mean Change in CD4+ T Lymphocyte Counts
The mean change in CD4+ T lymphocyte counts when participants have had Polyphenon E (800mg, 1200mg, 1600mg EGCG bid for 14 days).
Measured: Baseline to 14 days
Composite of Pharmacokinetics Time Frame: Predose, 0,0.5,1,1.5,2,3,4,6,8,12 Hours Post-dose
Plasma PK parameters of EGCG after single dose and at steady state (after 14 day EGCG treatment).
Measured: Predose, 0,0.5,1,1.5,2,3,4,6,8,12 Hours Post-dose on Days 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2014
- Study completionJul 2015
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.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Filiz Seeborg, Baylor College of Medicine
- Investigators
- Filiz Seeborg, MD, MPH, Principal investigator, Baylor College of MedicineRoberto Arduino, MD, Study director, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433289
- Sponsor's protocol ID
- H-21490
- Other IDs
- R21AT004673
- Status last verified
- Apr 2023
- First submitted
- 9 Sep 2011
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Dose-Blinded, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Polyphenon E (EGCG) 14 Day Monotherapy in Antiretroviral Naïve and Experienced, HIV-1-Infected Subjects
- ClinicalTrials.gov ID
- NCT01433289
- Acronym / sponsor ID
- H-21490
- Conditions
- HIV Infection
- Keywords
- HIV, safety, toxicity, pharmacokinetics, Polyphenon E, EGCG, green tea, CD4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Dec 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 19 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, toxicity, dosing, and antiviral effects of epigallocatechin gallate (EGCG) in capsule form (Polyphenon® E), administered orally twice daily at three different doses in HIV-1-infected clinically stable, treatment-naïve and treatment-experienced adults not on concomitant antiretroviral (ARV) therapy.
Detailed description
HIV-1 infection ultimately results in impaired specific immune function by virtue of the initial binding of the HIV-1 virion envelope glycoprotein 120 (gp120) to the CD4 receptor in complex with a chemokine receptor on the T-cell surface1. Even though gp120 elicits virus-neutralizing antibodies, HIV-1 eludes the immune system and leads to the onset of AIDS. Ever since the discovery of the virus as the causative agent, there has been an intense effort to develop therapeutic methods to inhibit or prevent infection.2-4 CD4, a cell surface glycoprotein expressed on T cells, plays an important role in the recognition of antigens by T cells and in their activation.5 It also acts as a receptor for HIV-1 as gp120 binds to it via its D1 domain and, uses this interaction to infect CD4+ T cells.5 Therefore, there has been interest in finding molecules that block the binding of gp120 to CD4 (entry inhibitors) as a way of reducing HIV-1 infectivity.
Studies have demonstrated evidence of high affinity binding of EGCG to the CD4 molecule with a Kd of 10nM with subsequent inhibition of gp120 binding to human CD4+ T cells. EGCG binds in the same molecular pocket on CD4, as does HIV-1-gp120 at physiologically relevant concentrations.
This is a phase I, placebo-controlled, dose-blinded, randomized study of Polyphenon® E as monotherapy in participants who are HIV-1-infected with a CD+ T lymphocyte count of at least 250 cells/mm3 and are ARV-naïve or ARV-experienced. There will be 3 dose levels and for each dose level, there will be 6 subjects who will receive the study drug and 2 subjects who will be randomized to take placebo. Dosing will be escalated sequentially contingent on the safety profile of previous doses. Safety data from all participants receiving Polyphenon® E in the preceding dose level will be evaluated and considered acceptable prior to escalation to the next higher dose. PK analyses will be also performed as each dose level is completed. If at least 4 subjects on the active drug in each dose level have evaluable PK data, subjects will not be replaced. As the inability to achieve adequate EGCG concentrations that are necessary to inhibit HIV-1 replication is a major concern in this study, it is necessary to confirm EGCG pharmacokinetics in the event that the primary outcome measure of virologic response is not observed for each dose level. For each PK visit on Study Days 1 and 14, a total of 10 blood samples will be obtained per subject. If only a few samples cannot be used (this depends on the individual subject's pharmacokinetic profile, although one or two unevaluable samples will not likely cause a subject's data to be unevaluable), PK analyses can still be performed and will not require subjects to be deemed unevaluable and replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Polyphenon E 1600 mg/day | Experimental | Drug: Polyphenon EDrug: Polyphenon E Polyphenon E capsules containing 200 mg of epigallocatechin-gallate. Four capsules twice a day. |
| Polyphenon E 2400 mg/day | Experimental | Drug: Polyphenon EDrug: Polyphenon E Polyphenon E capsules containing 200 mg of epigallocatechin-gallate. Six capsules twice a day. |
| Polyphenon E 3200 mg/day | Experimental | Drug: Polyphenon EDrug: Polyphenon E Polyphenon E capsules containing 200 mg of epigallocatechin-gallate. Eight capsules twice a day. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- HIV-infected individual as having at least two of the following in any combination obtained from 2 different samples: Positive HIV rapid test or ELISA and Western Blot; HIV RNA PCR>10,000 copies/ml; positive HIV DNA PCR; neutralizable HIV p 24 antigen
- Asymptomatic HIV-1 infected individuals who are either antiretroviral-naive or treatment-experienced. Subjects must have not been on ARV treatment for at least 12 weeks prior to enrollment and not have plans to start ARV treatment within 8 weeks of study initiation.
- Male or female 18 to 65 years of age. Males must use barrier methods of contraception Females must be willing to abide by protocol specified methods to avoid becoming pregnant. Women of childbearing potential must use an adequate form of birth control determined by the investigator (e.g., oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or vasectomy).
- HIV-1 RNA >1,000 copies/mL at Screening.
- In the opinion of the investigator, subject has a stable CD4+ T lymphocyte count while off ARV and 250 cells/mm3 at Screening.
Key exclusion criteria (22 listed)
- Current or recent (<3 months) history of opportunistic infection that,
- Acute illness within 1 week of the baseline visit.
- Participant is not able to comply with the dosing schedule and protocol evaluations.
- Participant is anticipated to begin ARV treatment during participation in the study.
- Pregnancy, breastfeeding or postpartum (less than 3 months).
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 |
|---|---|---|
| Polyphenon EAlso: EGCG, epigallocatechin gallate, green tea catechin, green tea extractThere will be 3 dose levels and for each dose level, there will be 6 subjects who will receive the study drug and 2 subjects who will be randomized to take placebo. Dosing will be escalated sequentially contingent on the safety profile of previous doses. Safety data from all participants receiving Polyphenon® E in the preceding dose level will be evaluated and considered acceptable prior to escalation to the next higher dose. PK analyses will be also performed as each dose level is completed. It is necessary to confirm EGCG pharmacokinetics in the event that the primary outcome measure of virologic response is not observed for each arm. For each PK visit on Study Days 1 and 14, a total of 10 blood samples will be obtained per subject. | Drug | Polyphenon E 1600 mg/day, Polyphenon E 2400 mg/day, Polyphenon E 3200 mg/day |
| Placebo | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 14 days
Safety of Polyphenon E (800mg, 1200mg, 1600mg EGCG twice daily for 14 days) in HIV-1-infected subjects.
Median Change of log10 HIV-1 RNA Copies/ml
Time frame: Baseline and 14 days
Median change of log10 HIV-1 RNA copies/ml from baseline in subjects who have completed 14 days of treatment (800mg, 1200mg, 1600mg EGCG bid) or placebo.
3 secondary outcomes
Number of Participants Achieving > 0.75 or 1.0 log10 Reduction in HIV-1 RNA or <400 Copies/ml
Time frame: Baseline to 14 days
The Mean Change in CD4+ T Lymphocyte Counts
Time frame: Baseline to 14 days
Composite of Pharmacokinetics Time Frame: Predose, 0,0.5,1,1.5,2,3,4,6,8,12 Hours Post-dose
Time frame: Predose, 0,0.5,1,1.5,2,3,4,6,8,12 Hours Post-dose on Days 1 and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Filiz Seeborg, MD, MPH principal investigator
Baylor College of Medicine
Roberto Arduino, MD study director
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polyphenon E in people with HIV Infection, run by Baylor College of Medicine at 2 sites in United States.
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 22 inclusion and 22 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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 19 May 2023). 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 Adverse Events (time frame: 14 days). 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?
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 19 May 2023.