HIV-1-infectionPhase 2NCT04120415
A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02)
A Phase 2 study testing Vaccine and vedolizumab (Entyvio) in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 4 sites in 3 countries.
Trial summary
EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Vaccine and vedolizumab (Entyvio)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 21 Jun 2022to 12 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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-1-infected
- Aged 18 - 65 years old on the day of screening
- Weight >50kg
- Willing and able to provide written informed consent
- Nadir CD4 count > 300 cells/mm3
- CD4 count at screening > 500 cells/mm3
Show all 16Show fewer
- Viral load <50 copies/ml at screening.
- Started cART after 2009 and on cART for at least one year prior to screening
- Willing to interrupt cART for up to 24 weeks and change cART regimen if required
- If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (which could include PrEP for their sexual partners)
- If heterosexually active and able to have children, willing to use a highly effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; physiological or anatomical sterility (in self or partner) from 2 weeks before enrolment until 18 weeks after the last injection/infusion
- If women of childbearing potential*, willing to undergo urine pregnancy tests prior to administration of an injection and an infusion
- Willing to avoid all other vaccines within 4 weeks of scheduled study injections
- Willing and able to comply with visit schedule and provide blood samples
- Being covered by medical insurance or in National Healthcare System
- A woman will be considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Who cannot join
- Pregnant or lactating
- HIV-2 infection (either isolated or associated with HIV-1)
- VL >200 copies/ml on 2 occasions in the 12 months prior to screening
- Previous interruptions in cART
- Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
- Haemoglobin (Hb <12g/dL for males, <11g/dL for females)
Show all 29Show fewer
- Concomitant or previous conditions that preclude injection of vaccines/infusion of monoclonal antibody and PML in the past
- History of experimental vaccinations against HIV
- Previous treatment with chemotherapy (except for chemotherapy injected into skin lesions for Kaposi's sarcoma)
- Treatment with systemic corticoids or immuno-suppressive agents ongoing or in the 12 weeks prior to randomisation in the trial
- Received natalizumab or rituximab ever in the past
- Received a TNF blocker in the past 60 days
- Administration of an inactivated vaccine within 30 days or a live vaccine within 60 days prior to randomisation
- Presence of a skin condition or marking that precludes inspection of the injection/infusion site
- History of cancer (except basal cellular skin carcinoma or Kaposi's sarcoma)
- History of significant neurological disease or cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke); participants with controlled blood pressure are eligible
- History of clinical autoimmune disease
- Ongoing diseases including uncontrolled active severe infection, cardiac, pulmonary (excluding mild asthma), thyroid, renal or neurological (peripheral or central) diseases
- Active or latent tuberculosis (unless prophylaxis in past as per local practice) - (participant must be screened for tuberculosis before starting infusions, according to routine practice)
- Presence of pathogenic bacteria or parasites in faeces at screening
- Participating in another biomedical research study within 30 days of randomisation
- Known hypersensitivity to any component of the vaccine formulation used in this trial including eggs or have severe or multiple allergies to drugs or pharmaceutical agents, or any hypersensitivity to the active substance or to any of the excipients of vedolizumab.
- Liver disease including hepatitis B (surface antigen positive) or hepatitis C (antigen or PCR positive)
- A clinically significant abnormality on ECG
- Hypernatraemia or hyperchloraemia
- History of severe local or general reaction to vaccination defined as
- local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
- general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- Grade 2 or worse routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Service Immunologie clinique et maladies infectieuses, Hôpital Henri Mondor
Paris, Creteil, 94010
Hotel Dieu
Paris, 75004
Switzerland1 site
Centre d'Immunothérapie et Vaccinologie, CHUV
Lausanne, Canton of Vaud, 1011
United Kingdom1 site
St Stephens Centre, Chelsea & Westminster Hospital
London, SW10 9NH
About this study
Official title: EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: A Phase II Randomised, Placebo-controlled Trial of Vedolizumab With or Without Therapeutic HIV MVA Vaccine in Individuals Who Started Antiretrovirals During Primary or Chronic Infection
EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.
Read the detailed description
Screening will take place during the 6 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to MVA HIV-B vaccine followed by vedolizumab, vedolizumab + placebo vaccine, or placebo vaccine + placebo infusions.
Participants will be randomised at each centre through web-based randomisation after entering the eligibility criteria. There will be two strata: one for those who started treatment during primary infection, and one for those who started treatment during chronic infection.
69 eligible individuals from collaborating European Countries will be enrolled, aiming for approximately half who started cART in primary infection and half who started in chronic infection. Participants continue from the screening visit (up to 6 weeks before enrolment) to the last visit, a maximum of 60 weeks (around 14 months), although follow-up will continue through to the time when virus is fully suppressed.
Treatment will be interrupted at week 18 and resumed when the viral load is confirmed to have rebounded to ≥100,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, confirmed, or there is evidence of disease progression, or they have completed 24 weeks of treatment interruption.
- Conditions
- HIV-1-infection
- Being tested
- Vaccine and vedolizumab (Entyvio), Placebo vaccine and vedolizumab infusion (Entyvio), Placebo vaccine and placebo infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine and vedolizumab (Entyvio)Biological
Vaccine and vedolizumab infusion (Entyvio):
0.5ml of MVA HIV-B (1 x 108 pfu/ml) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection.
Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion.
Placebo vaccine and vedolizumab infusion (Entyvio)Biological
Placebo Vaccine:
The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection.
Vedolizumab infusion (Entyvio):
Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion.
Placebo vaccine and placebo infusionBiological
Placebo Vaccine:
The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection.
Placebo infusion (Entyvio):
255ml Sodium Chloride (NaCl) 0.9% bag administered as an intravenous infusion over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. Participants will be observed throughout and after the infusion.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine and Vedolizumab infusion | Experimental | Vaccine:
The vaccine is MVA HIV-B which is a solution of HIV MVA vectors in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0).
Vedolizumab infusion (Entyvio):
Vedolizumab (300mg) is administered as an intravenous infusion (255 ml). Receives: Biological: Vaccine and vedolizumab (Entyvio) |
| Placebo vaccine and Vedolizumab infusion | Experimental | Placebo vaccine:
The placebo for MVA HIV-B to be used in this trial is a solution composed of S08 buffer (as for the MVA vaccine).
Vedolizumab infusion (Entyvio):
Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) Receives: Biological: Placebo vaccine and vedolizumab infusion (Entyvio) |
| Placebo vaccine and placebo infusion | Placebo comparator | Placebo vaccine:
The placebo for MVA HIV-B to be used in this trial is a solution composed of S08 buffer (as for the MVA vaccine).
Placebo infusion:
Sodium Chloride (NaCl) 0.9% administered as an intravenous infusion (255ml) Receives: Biological: Placebo vaccine and placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the HIV RNA curve
Area under the HIV RNA curve from treatment interruption (scheduled for 18 weeks after entering the trial)
Measured: Time from treatment interruption (scheduled for 18 weeks after entering the trial) to 24 weeks post-treatment interruption
Secondary outcomes (6)
Virological outcome measures
Time from treatment interruption (scheduled for 18 weeks after entering the trial) to the earliest of reaching HIV RNA ≥ 100 000 copies/ml (confirmed on a separate sample) or resuming antiretroviral therapy for any reason over a period of 24 weeks.
Measured: For participants commencing treatment interruption only, critical time points weeks 19 through to to week 42.
Virological outcome measures
Level of HIV total RNA
Measured: From randomisation to study completion about 54 weeks
Virological outcome measures
Cell Associated (CA) HIV RNA Quantification
Measured: From randomisation to study completion about 54 weeks
Virological outcome measures
First local maximum (peak) level of HIV total RNA during treatment interruption
Measured: Time from treatment interruption, only in participants commencing treatment interruption, up to 24 weeks after ATI
Virological outcome measures
Rate of increase of HIV total RNA between the last measure below the lower detection and the first local maximum
Measured: Time from treatment interruption, only in participants commencing treatment interruption, up to 24 weeks after ATI
Virological outcome measures
Setpoint (two stable measures following a transient increase of HIV RNA)
Measured: Time from treatment interruption, only in participants commencing treatment interruption, up to 24 weeks after ATI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start21 Jun 2022
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- EuroVacc Foundation, European AIDS Treatment Group (EATG), Medical Research Council, University College London Hospitals, University of Liverpool, Erasmus Medical Center, Henri Mondor University Hospital, European Georges Pompidou Hospital, Saint-Louis Hospital, Paris, France, Centre Hospitalier Universitaire Vaudois, Chelsea and Westminster NHS Foundation Trust, Universitätsklinikum Hamburg-Eppendorf, Hospital Clinic of Barcelona, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, Imperial College London, Institut d'Investigacions Biomèdiques August Pi i Sunyer, European Commission, Swiss Government
- Responsible party
- Sponsor
- Investigators
- Yves Levy, MD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120415
- Sponsor's protocol ID
- EHVA T02/ANRS VRI07
- Status last verified
- Jul 2023
- First submitted
- 30 Sep 2019
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: A Phase II Randomised, Placebo-controlled Trial of Vedolizumab With or Without Therapeutic HIV MVA Vaccine in Individuals Who Started Antiretrovirals During Primary or Chronic Infection
- ClinicalTrials.gov ID
- NCT04120415
- Acronym / sponsor ID
- EHVA T02/ANRS VRI07
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- EuroVacc Foundation, European AIDS Treatment Group (EATG), Medical Research Council, University College London Hospitals, University of Liverpool, Erasmus Medical Center, Henri Mondor University Hospital, European Georges Pompidou Hospital, Saint-Louis Hospital, Paris, France, Centre Hospitalier Universitaire Vaudois, Chelsea and Westminster NHS Foundation Trust, Universitätsklinikum Hamburg-Eppendorf, Hospital Clinic of Barcelona, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, Imperial College London, Institut d'Investigacions Biomèdiques August Pi i Sunyer, European Commission, Swiss Government
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.
Detailed description
Screening will take place during the 6 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to MVA HIV-B vaccine followed by vedolizumab, vedolizumab + placebo vaccine, or placebo vaccine + placebo infusions.
Participants will be randomised at each centre through web-based randomisation after entering the eligibility criteria. There will be two strata: one for those who started treatment during primary infection, and one for those who started treatment during chronic infection.
69 eligible individuals from collaborating European Countries will be enrolled, aiming for approximately half who started cART in primary infection and half who started in chronic infection. Participants continue from the screening visit (up to 6 weeks before enrolment) to the last visit, a maximum of 60 weeks (around 14 months), although follow-up will continue through to the time when virus is fully suppressed.
Treatment will be interrupted at week 18 and resumed when the viral load is confirmed to have rebounded to ≥100,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, confirmed, or there is evidence of disease progression, or they have completed 24 weeks of treatment interruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine and Vedolizumab infusion | Experimental | Biological: Vaccine and vedolizumab (Entyvio)Vaccine: The vaccine is MVA HIV-B which is a solution of HIV MVA vectors in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0). Vedolizumab infusion (Entyvio): Vedolizumab (300mg) is administered as an intravenous infusion (255 ml). |
| Placebo vaccine and Vedolizumab infusion | Experimental | Biological: Placebo vaccine and vedolizumab infusion (Entyvio)Placebo vaccine: The placebo for MVA HIV-B to be used in this trial is a solution composed of S08 buffer (as for the MVA vaccine). Vedolizumab infusion (Entyvio): Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) |
| Placebo vaccine and placebo infusion | Placebo comparator | Biological: Placebo vaccine and placebo infusionPlacebo vaccine: The placebo for MVA HIV-B to be used in this trial is a solution composed of S08 buffer (as for the MVA vaccine). Placebo infusion: Sodium Chloride (NaCl) 0.9% administered as an intravenous infusion (255ml) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1-infected
- Aged 18 - 65 years old on the day of screening
- Weight >50kg
- Willing and able to provide written informed consent
- Nadir CD4 count > 300 cells/mm3
Key exclusion criteria (29 listed)
- Pregnant or lactating
- HIV-2 infection (either isolated or associated with HIV-1)
- VL >200 copies/ml on 2 occasions in the 12 months prior to screening
- Previous interruptions in cART
- Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
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 |
|---|---|---|
| Vaccine and vedolizumab (Entyvio)Vaccine and vedolizumab infusion (Entyvio): 0.5ml of MVA HIV-B (1 x 108 pfu/ml) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection. Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion. | Biological | Vaccine and Vedolizumab infusion |
| Placebo vaccine and vedolizumab infusion (Entyvio)Placebo Vaccine: The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection. Vedolizumab infusion (Entyvio): Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion. | Biological | Placebo vaccine and Vedolizumab infusion |
| Placebo vaccine and placebo infusionPlacebo Vaccine: The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection. Placebo infusion (Entyvio): 255ml Sodium Chloride (NaCl) 0.9% bag administered as an intravenous infusion over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. Participants will be observed throughout and after the infusion. | Biological | Placebo vaccine and placebo infusion |
Primary outcome
Area under the HIV RNA curve
Time frame: Time from treatment interruption (scheduled for 18 weeks after entering the trial) to 24 weeks post-treatment interruption
Area under the HIV RNA curve from treatment interruption (scheduled for 18 weeks after entering the trial)
6 secondary outcomes
Virological outcome measures
Time frame: For participants commencing treatment interruption only, critical time points weeks 19 through to to week 42.
Virological outcome measures
Time frame: From randomisation to study completion about 54 weeks
Virological outcome measures
Time frame: From randomisation to study completion about 54 weeks
Virological outcome measures
Time frame: Time from treatment interruption, only in participants commencing treatment interruption, up to 24 weeks after ATI
Virological outcome measures
Time frame: Time from treatment interruption, only in participants commencing treatment interruption, up to 24 weeks after ATI
Virological outcome measures
Time frame: Time from treatment interruption, only in participants commencing treatment interruption, up to 24 weeks after ATI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Yves Levy, MD study director
Institut National de la Santé Et de la Recherche Médicale, France
4 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 Vaccine and vedolizumab (Entyvio) in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 4 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 16 inclusion and 29 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Switzerland, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the HIV RNA curve (time frame: Time from treatment interruption (scheduled for 18 weeks after entering the trial) to 24 weeks post-treatment interruption). 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 4 Aug 2023.