HIV InfectionsPhase 2RADIANT-TBNCT03851588
Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis
A Phase 2 study testing Dolutegravir 50 mg in people with HIV Infections and Tuberculosis, run by University of Cape Town at 1 site in South Africa.
Trial summary
The investigators propose to conduct a phase 2 randomised (1:1) double-blind placebo-controlled trial of the dolutegravir-lamivudine-tenofovir fixed dose combination tablet daily with an additional 50 mg dose of dolutegravir/matching placebo taken 12 hours later in ART-naïve or fisrt-line interrupted HIV-infected… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Dolutegravir 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSouth Africa
- Study dates
- 19 Dec 2019to 28 Jun 2022
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection as documented by screening plasma HIV-1 RNA >1000 c/mL
- ART-naïve (short-term antiretroviral use for prevention of mother-to-child transmission will be allowed) or
- ART treatment interrupters on ART <6 months prior to interruption or virologically suppressed (<50 copies/mL or LDL) <6 months prior to interruption
- On rifampicin-based therapy for tuberculosis for <3 months
- CD4 counts >100 cells/µL
- Women of child-bearing potential willing to use adequate contraception (defined as either an intrauterine contraceptive device or hormonal contraception as per national guidelines)
Who cannot join
- Pregnant/breastfeeding
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease (MDRD) study)
- Alanine aminotransferase >3 times upper limit of normal (ULN)
- Allergy or intolerance to one of the drugs in regimen
- Concomitant medication known to significantly reduce or increase dolutegravir exposure (except rifampicin)
- Active psychiatric disease or substance abuse
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- On treatment for active AIDS-defining condition other than tuberculosis (participants on maintenance therapy may be enrolled)
- Malignancy
- Any other clinical condition that in the opinion of an investigator puts the patient at increased risk of participating in the study.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Khayelitsha Site B/Ubuntu Clinic
Cape Town, Western Cape, 8001
About this study
Official title: Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis: a Phase 2 Non-comparative Randomised Controlled Trial
The investigators propose to conduct a phase 2 randomised (1:1) double-blind placebo-controlled trial of the dolutegravir-lamivudine-tenofovir fixed dose combination tablet daily with an additional 50 mg dose of dolutegravir/matching placebo taken 12 hours later in ART-naïve or fisrt-line interrupted HIV-infected patients on rifampicin-based anti-tuberculosis therapy. The hypothesis is that virologic outcomes with standard dose dolutegravir-based ART will be acceptable in patients on rifampicin-based anti-tuberculosis therapy.
Read the detailed description
Dolutegravir is being rolled out to replace efavirenz in first-line antiretroviral therapy (ART) in low-middle income countries (LMICs) because it is more effective, better tolerated, and has a considerably higher genetic barrier to resistance.
Tuberculosis is the commonest cause of HIV-related morbidity and mortality in LMICs. Rifampicin, which is a key component of anti-tuberculosis therapy, induces genes that are important in the metabolism and transport of dolutegravir. The resulting drug-drug interaction between dolutegravir and rifampicin significantly reduces dolutegravir exposure, which can be overcome by increasing the dose of dolutegravir to 50 mg 12 hourly.
The additional dose of dolutegravir will be difficult to implement in high burden settings. Furthermore, the additional dolutegravir tablet increases pill burden and costs. If standard dose dolutegravir is shown to be effective in patients with tuberculosis this would sweep away one of the major barriers to its implementation in LMICs. There are three lines of evidence to support studying standard dose dolutegravir in patients with HIV-associated tuberculosis.
First, there are compelling pharmacokinetic and pharmacodynamic data supporting the therapeutic efficacy of lower dolutegravir exposure. Second, the investigators have conducted a drug-drug interaction study of dolutegravir dosed at 50 mg or 100 mg once daily in healthy volunteers with rifampicin. Although, as expected, concomitant rifampicin significantly reduced dolutegravir exposure at both doses, all dolutegravir trough concentrations on rifampicin were above the protein-adjusted 90% inhibitory concentration (PA IC90). Third, exposure to the first-generation integrase inhibitor raltegravir is also significantly reduced with concomitant rifampicin. A phase 2 study in patients with HIV-associated tuberculosis showed that virologic outcomes were similar with standard and double dose raltegravir. It is plausible that findings could be similar with dolutegravir.
The hypothesis is that virologic outcomes with standard dose dolutegravir-based ART will be acceptable in patients on rifampicin-based anti-tuberculosis therapy. If the proportion of participants who achieve virological suppression on standard dose dolutegravir is acceptable, this would pave the way for a phase 3 trial of dolutegravir 50 mg daily versus an appropriate standard of care regimen, like efavirenz-based ART, in patients with HIV-associated tuberculosis.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Placebo, Dolutegravir 50 mg
- Keywords
- Antiretroviral therapy, Dolutegravir, Rifampicin, Tuberculosis, Drug-drug interaction
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is not given with a supplementary dose of dolutegravir 50 mg.
Dolutegravir 50 mgDrug
Also called Tivicay 50 mg
Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is given with a supplementary dose of dolutegravir 50 mg.
| Study group | Role | What they receive |
|---|---|---|
| Supplementary dose | Active comparator | Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily with an additional dolutegravir 50 mg dose taken 12 hours later. Receives: Drug: Dolutegravir 50 mg |
| Placebo dose | Placebo comparator | Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily with placebo taken 12 hours later. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological Suppression at 24 Weeks
Proportion with HIV viral load <50 copies/mL at 24 weeks analysed by modified intention to treat (ITT), which includes all participants who received at least one dose of dolutegravir, and according to the FDA snapshot algorithm.
Measured: 24 weeks
Secondary outcomes (13)
Virological Suppression at 12 Weeks (Modified ITT)
Proportion with HIV viral load <50 copies/mL at 12 weeks analyzed modified ITT.
Measured: 12 weeks
Virological Suppression at 24 Weeks (Per Protocol)
Proportion with HIV viral load <50 copies/mL at 24 weeks analyzed per protocol.
Measured: 24 weeks
Virological Suppression at 48 Weeks (Modified ITT)
Proportion with HIV viral load <50 copies/mL at 48 weeks analyzed modified ITT.
Measured: 48 weeks
Virological Suppression at 48 Weeks (Per Protocol)
Proportion with HIV viral load <50 copies/mL at 48 weeks analyzed per protocol.
Measured: 48 weeks
CD4 Change at 24 Weeks
Change in CD4 count from screening at week 24.
Measured: 24 weeks
Dolutegravir Trough Concentrations
Proportion with dolutegravir trough concentrations above the PA IC90 at week 24
Measured: 24 weeks
Grade 3 or 4 Adverse Events
Grade 3 or 4 drug-related adverse events will be accessed throughout the trial.
Measured: 48 weeks
Change in Sleep Assessment From Baseline - Any Treatment Emergent Insomnia After Baseline Assessed at 4 Weekly Intervals Until Week 24 and Then Again at Week 48
Insomnia severity index (ISI scored from 0-28. Score categories: 0-7, no clinical significant insomnia; 8-14, sub-threshold insomnia; 15-21, clinical insomnia (moderate severity); 22-28, clinical insomnia (severe). Measures sleep patterns and how this influences daily functioning and quality of life (assessed through 48 weeks). Measure of participants with treatment emergent insomnia from baseline
Measured: Through 48 weeks
Change in Mental Health Assessment From Baseline Through Week 48
Modified MINI screen (MMS) Mental health questionnaire will be assessed by given at baseline, 12 weeks, 24 weeks, and 48 weeks. The questionnaire is standardized and has been based on the mini international neuropsychiatric interview (version 7.0.0). All questions in the questionnaire require a yes/no answer.
MMS score increased is worsening MMS includes 22 questions answered yes/no; 2 questions related to experiencing a traumatic event were excluded for a 20 point scale.
MMS was measured at baseline, week 12, and week 24
Presenting number of participants with increase in MMS of at least 1 point from baseline through 48 weeks.
Measured: Through 48 weeks
Serious Adverse Events
Document any serious adverse events that occur throughout the trial.
Measured: 48 weeks
Adverse Events Requiring Discontinuation of an ART Drug
Any adverse event that requires discontinuation of any drug in the ART regimen throughout the trial.
Measured: 48 weeks
Antiretroviral Resistance Mutations Testing by Genotypic Resistance Assay in Participants With Virologic Failure
If a viral load is >1000 copies/mL at week 24 or at week 48, or if the viral load was suppressed and then rebounded to >1000 copies/mL, a sample will be taken for resistance testing. Antiretroviral resistance mutations in participants with virologic failure will be assessed by genotypic resistance assay and compared to stored plasma at baseline to distinguish emergent from pre-treatment resistance.
Any ART resistance mutations in participants with virological failure by week 48.
Measured: Through 48 weeks
Primary Outcome Differences Among ART-naïve Versus First-line Interruption Status
The primary outcome measure (proportion with HIV viral load <50 copies/mL at 24 weeks analysed by modified intention to treat (ITT), which includes all participants who received at least one dose of dolutegravir, and according to the FDA snapshot algorithm) will be stratified by ART-naïve versus first-line interruption status.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start19 Dec 2019
- Primary completion20 Jan 2022
- Study completion28 Jun 2022
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 (2)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
- Model description
- Parallel assignment of randomised groups with stratification by ART-naïve versus first-line interrupter status
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Medecins Sans Frontieres, Netherlands
- Responsible party
- Principal investigator, Prof Gary Maartens, University of Cape Town
- Investigators
- Gary Maartens, MMed, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851588
- Sponsor's protocol ID
- CIDRI003
- Acronym
- RADIANT-TB
- Status last verified
- Jun 2024
- First submitted
- 15 Feb 2019
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other organizations or individuals for further research upon a reasonable request to the University of Cape Town PI, provided that certain conditions are met (including but not limited to the ethical standards upheld by HREC that approved the initial study.
Publications
Griesel R, Zhao Y, Simmons B, Omar Z, Wiesner L, Keene CM, Hill AM, Meintjes G, Maartens G. Standard-dose versus double-dose dolutegravir in HIV-associated tuberculosis in South Africa (RADIANT-TB): a phase 2, non-comparative, randomised controlled trial. Lancet HIV. 2023 Jul;10(7):e433-e441. doi: 10.1016/S2352-3018(23)00081-4. Epub 2023 May 22.
PubMed 37230101Griesel R, Hill A, Meintjes G, Maartens G. Standard versus double dose dolutegravir in patients with HIV-associated tuberculosis: a phase 2 non-comparative randomised controlled (RADIANT-TB) trial. Wellcome Open Res. 2021 Jan 11;6:1. doi: 10.12688/wellcomeopenres.16473.1. eCollection 2021.
PubMed 33954265
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis: a Phase 2 Non-comparative Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03851588
- Acronym / sponsor ID
- RADIANT-TB / CIDRI003
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Antiretroviral therapy, Dolutegravir, Rifampicin, Tuberculosis, Drug-drug interaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Wellcome Trust, Medecins Sans Frontieres, Netherlands
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to conduct a phase 2 randomised (1:1) double-blind placebo-controlled trial of the dolutegravir-lamivudine-tenofovir fixed dose combination tablet daily with an additional 50 mg dose of dolutegravir/matching placebo taken 12 hours later in ART-naïve or fisrt-line interrupted HIV-infected patients on rifampicin-based anti-tuberculosis therapy. The hypothesis is that virologic outcomes with standard dose dolutegravir-based ART will be acceptable in patients on rifampicin-based anti-tuberculosis therapy.
Detailed description
Dolutegravir is being rolled out to replace efavirenz in first-line antiretroviral therapy (ART) in low-middle income countries (LMICs) because it is more effective, better tolerated, and has a considerably higher genetic barrier to resistance.
Tuberculosis is the commonest cause of HIV-related morbidity and mortality in LMICs. Rifampicin, which is a key component of anti-tuberculosis therapy, induces genes that are important in the metabolism and transport of dolutegravir. The resulting drug-drug interaction between dolutegravir and rifampicin significantly reduces dolutegravir exposure, which can be overcome by increasing the dose of dolutegravir to 50 mg 12 hourly.
The additional dose of dolutegravir will be difficult to implement in high burden settings. Furthermore, the additional dolutegravir tablet increases pill burden and costs. If standard dose dolutegravir is shown to be effective in patients with tuberculosis this would sweep away one of the major barriers to its implementation in LMICs. There are three lines of evidence to support studying standard dose dolutegravir in patients with HIV-associated tuberculosis.
First, there are compelling pharmacokinetic and pharmacodynamic data supporting the therapeutic efficacy of lower dolutegravir exposure. Second, the investigators have conducted a drug-drug interaction study of dolutegravir dosed at 50 mg or 100 mg once daily in healthy volunteers with rifampicin. Although, as expected, concomitant rifampicin significantly reduced dolutegravir exposure at both doses, all dolutegravir trough concentrations on rifampicin were above the protein-adjusted 90% inhibitory concentration (PA IC90). Third, exposure to the first-generation integrase inhibitor raltegravir is also significantly reduced with concomitant rifampicin. A phase 2 study in patients with HIV-associated tuberculosis showed that virologic outcomes were similar with standard and double dose raltegravir. It is plausible that findings could be similar with dolutegravir.
The hypothesis is that virologic outcomes with standard dose dolutegravir-based ART will be acceptable in patients on rifampicin-based anti-tuberculosis therapy. If the proportion of participants who achieve virological suppression on standard dose dolutegravir is acceptable, this would pave the way for a phase 3 trial of dolutegravir 50 mg daily versus an appropriate standard of care regimen, like efavirenz-based ART, in patients with HIV-associated tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment of randomised groups with stratification by ART-naïve versus first-line interrupter status
| Arm | Type | Receives |
|---|---|---|
| Supplementary dose | Active comparator | Drug: Dolutegravir 50 mgDolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily with an additional dolutegravir 50 mg dose taken 12 hours later. |
| Placebo dose | Placebo comparator | Other: PlaceboDolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily with placebo taken 12 hours later. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 infection as documented by screening plasma HIV-1 RNA >1000 c/mL
- ART-naïve (short-term antiretroviral use for prevention of mother-to-child transmission will be allowed) or
- ART treatment interrupters on ART <6 months prior to interruption or virologically suppressed (<50 copies/mL or LDL) <6 months prior to interruption
- On rifampicin-based therapy for tuberculosis for <3 months
- CD4 counts >100 cells/µL
Key exclusion criteria (9 listed)
- Pregnant/breastfeeding
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease (MDRD) study)
- Alanine aminotransferase >3 times upper limit of normal (ULN)
- Allergy or intolerance to one of the drugs in regimen
- Concomitant medication known to significantly reduce or increase dolutegravir exposure (except rifampicin)
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 |
|---|---|---|
| PlaceboDolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is not given with a supplementary dose of dolutegravir 50 mg. | Other | Placebo dose |
| Dolutegravir 50 mgAlso: Tivicay 50 mgDolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is given with a supplementary dose of dolutegravir 50 mg. | Drug | Supplementary dose |
Primary outcome
Virological Suppression at 24 Weeks
Time frame: 24 weeks
Proportion with HIV viral load <50 copies/mL at 24 weeks analysed by modified intention to treat (ITT), which includes all participants who received at least one dose of dolutegravir, and according to the FDA snapshot algorithm.
13 secondary outcomes
Virological Suppression at 12 Weeks (Modified ITT)
Time frame: 12 weeks
Virological Suppression at 24 Weeks (Per Protocol)
Time frame: 24 weeks
Virological Suppression at 48 Weeks (Modified ITT)
Time frame: 48 weeks
Virological Suppression at 48 Weeks (Per Protocol)
Time frame: 48 weeks
CD4 Change at 24 Weeks
Time frame: 24 weeks
Dolutegravir Trough Concentrations
Time frame: 24 weeks
Grade 3 or 4 Adverse Events
Time frame: 48 weeks
Change in Sleep Assessment From Baseline - Any Treatment Emergent Insomnia After Baseline Assessed at 4 Weekly Intervals Until Week 24 and Then Again at Week 48
Time frame: Through 48 weeks
Change in Mental Health Assessment From Baseline Through Week 48
Time frame: Through 48 weeks
Serious Adverse Events
Time frame: 48 weeks
Adverse Events Requiring Discontinuation of an ART Drug
Time frame: 48 weeks
Antiretroviral Resistance Mutations Testing by Genotypic Resistance Assay in Participants With Virologic Failure
Time frame: Through 48 weeks
Primary Outcome Differences Among ART-naïve Versus First-line Interruption Status
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37230101Griesel R, Zhao Y, Simmons B, Omar Z, Wiesner L, Keene CM, Hill AM, Meintjes G, Maartens G. Standard-dose versus double-dose dolutegravir in HIV-associated tuberculosis in South Africa (RADIANT-TB): a phase 2, non-comparative, randomised controlled trial. Lancet HIV. 2023 Jul;10(7):e433-e441. doi: 10.1016/S2352-3018(23)00081-4. Epub 2023 May 22.
- Derived from this study: PubMed 33954265Griesel R, Hill A, Meintjes G, Maartens G. Standard versus double dose dolutegravir in patients with HIV-associated tuberculosis: a phase 2 non-comparative randomised controlled (RADIANT-TB) trial. Wellcome Open Res. 2021 Jan 11;6:1. doi: 10.12688/wellcomeopenres.16473.1. eCollection 2021.
- Individual participant dataSharing planned: Yes. Data will be shared with other organizations or individuals for further research upon a reasonable request to the University of Cape Town PI, provided that certain conditions are met (including but not limited to the ethical standards upheld by HREC that approved the initial study.
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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.
Gary Maartens, MMed principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dolutegravir 50 mg in people with HIV Infections and Tuberculosis, run by University of Cape Town at 1 site in South Africa.
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 6 inclusion and 9 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 18 Jul 2024. 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 South Africa. 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 18 Sep 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?
Virological Suppression at 24 Weeks (time frame: 24 weeks). 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 NCT03851588, which also lists 2 linked publications.
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 18 Jul 2024.