HIV -1 InfectionPhase 4CREATENCT07637942
Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
A Phase 4 study testing Every 4-week long-acting injectable cabotegravir and rilpivirine in people with HIV -1 Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 10 sites in United States.
Trial summary
Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV -1 Infection
- What is being tested?
- Every 4-week long-acting injectable cabotegravir and rilpivirine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Oct 2026to 22 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent for study participation for self and infant
- At screening, age 18 years or older
- Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry
- At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up
- Was diagnosed with HIV prior to the current pregnancy
- Has a documented plasma HIV RNA result less than 50 copies/mL from a specimen collected within 28 days prior to entry
- Has the following laboratory test results from a specimen collected within 28 days prior to entry (1) Grade 2 or lower platelets (greater than or equal to 50,000 cells/mm3 or greater than or equal to 50.00 x 109 cells/L); (2) Grade 1 or lower ALT (less than 2.5 x upper limit of normal; (3) Grade 1 or lower aspartate aminotransferase (AST)
- Received first dose of CAB LA + RPV LA prior to entry (before or after conception of the current pregnancy) and is expected to receive CAB LA + RPV LA on a Q4W schedule for the duration of study participation
Who cannot join
- History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)
- Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV; (3) Current contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which may interfere with the interpretation of ISRs; (4) Current use or anticipated need of therapeutic anticoagulation; (5) History of known or suspected bleeding disorder; (6) Current severe hepatic impairment (Class C) as determined by Child-Pugh classification; (7) History of suicidal ideation or attempt within six months of entry; (8) History of unstable or poorly controlled seizure disorder; (9) Current tuberculosis infection; (10) Current cervical intraepithelial neoplasia (CIN) 2 or 3, or malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma
- Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta; (2) Cervical cerclage/cervical incompetence; (3) Abnormal fetal anatomy
- Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome; (2) Intrauterine fetal demise (EGA greater than 20 weeks) without known nonrecurrent etiology; (3) Spontaneous very preterm delivery (less than 32 weeks); (4) Very LBW (less than 1500 g); (5) Cervical or abdominal cerclage due to cervical incompetence
- Receipt of any prohibited medication within seven days prior to entry
- Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV
- Receipt of an investigational agent or chemotherapy within 30 days prior to study entry
- Adult-participant or fetus has any condition, such as uncontrolled diabetes, hypertension, or other comorbidities, that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Not yet recruiting
Site 5030, Emory University School of Medicine
Atlanta, Georgia, 30322
Martina Badell, MD, 404-778-3401, mbadell@emory.edu
- Recruiting
Site 5052, University of Colorado
Aurora, Colorado, 80045
Lisa Abuogi, MD, 303-358-5061, Lisa.Abuogi@childrenscolorado.org
- Not yet recruiting
Site 5092, Johns Hopkins University
Baltimore, Maryland, 21287
Allison Agwu, MD, 410-614-3917, ageorg10@jhmi.edu
- Recruiting
Site 4001, Lurie Children's Hospital of Chicago CRS
Chicago, Illinois, 60614
Jennifer Jao, MD, MPH, 312-227-4080, jjao@luriechildrens.org
- Recruiting
Site 5128, Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
Mary Paul, MD, 832-822-1038, mpaul@bcm.edu
- Not yet recruiting
Site 4601, University of California, UC San Diego CRS
La Jolla, California, 92093
Stephen Spector, MD, 858-534-7055, saspector@ucsd.edu
- Not yet recruiting
Site 5048, University of Southern California
Los Angeles, California, 90033
Alice Stek, MD, 323-226-3353, stek@usc.edu
- Not yet recruiting
Site 6501, St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Katherine Knapp, MD, 901-595-4645, katherine.knapp@stjude.org
- Recruiting
Site 6201, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
William Short, MD, 267-971-3275, william.short@pennmedicine.upenn.edu
- Not yet recruiting
Site 5013, Jacobi Medical Center Bronx
The Bronx, New York, 10461
Andrew Wiznia, MD, 718-918-4664, andrew.wiznia@einsteinmed.edu
About this study
Official title: Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States
Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.
Read the detailed description
Up to 40 adult-participants with HIV viral suppression will be enrolled, in pairs with their infants, to achieve 30 evaluable adult-participants overall. The study will include women who initiated CAB LA + RPV LA outside the study, prior to study entry, either pre-conception (including on the day of conception) or post-conception.
- Conditions
- HIV -1 Infection
- Being tested
- Every 4-week long-acting injectable cabotegravir and rilpivirine
- Keywords
- HIV, Pregnancy, CAB LA + RPV LA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Every 4-week long-acting injectable cabotegravir and rilpivirineDrug
Long-acting injectable cabotegravir and rilpivirine, initiated pre-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.
Every 4-week long-acting injectable cabotegravir and rilpivirineDrug
Long-acting injectable cabotegravir and rilpivirine, initiated post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider.
| Study group | Role | What they receive |
|---|---|---|
| CAB LA + RPV LA Initiation Pre Conception | Experimental | Pregnant women with controlled HIV who were using CAB LA + RPV LA pre-conception, and continue to receive Q4W CAB LA + RPV LA Receives: Drug: Every 4-week long-acting injectable cabotegravir and rilpivirine |
| CAB LA + RPV LA Initiation Post Conception | Experimental | Pregnant women with controlled HIV who switch from oral SOC and initiate Q4W CAB LA + RPV LA post-conception, and continue to receive CAB LA + RPV LA Receives: Drug: Every 4-week long-acting injectable cabotegravir and rilpivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Measured: Measured from study entry through six weeks postpartum
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Measured: Measured from study entry through six weeks postpartum
Secondary outcomes (17)
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Measured: Delivery
Percentage of adult participants with virologic escape
Percentage of adult participants with virologic escape, defined as a single measurement of HIV RNA greater than or equal to 200 copies/mL
Measured: Measured from study entry through six weeks postpartum
Percentage of adult participants with confirmed virologic failure
Percentage of adult participants with confirmed virologic failure, defined as two successive HIV RNA test results greater than or equal to 200 copies/mL from separate specimens collected at least two weeks apart
Measured: Through 6 weeks postpartum
Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure
Number of adult participants with HIV resistance to CAB or RPV using IAS-USA, in participants who experienced confirmed virologic failure
Measured: Through 6 weeks postpartum
Number of infant participants with perinatal transmission
Number of infant participants with perinatal transmission
Measured: Birth and six weeks post-birth
Percentage of adult participants with at least one Grade 3 or higher adverse event
Percentage of adult participants with at least one Grade 3 or higher adverse event
Measured: Measured from study entry through six weeks postpartum
Percentage of adult participants with at least one serious adverse event
Percentage of adult participants with at least one serious adverse event
Measured: Measured from study entry through six weeks postpartum
Percentage of infant participants with at least one serious adverse event
Percentage of infant participants with at least one serious adverse event
Measured: Measured from birth through six weeks post-birth
Percentage of adult participants with spontaneous abortion
Percentage of adult participants with spontaneous abortion less than 20 weeks gestation
Measured: Through 6 weeks postpartum
Percentage of adult participants with fetal demise/stillbirth
Percentage of adult participants with fetal demise/stillbirth, at greater than or equal to 20 weeks gestation
Measured: Through 6 weeks postpartum
Percentage of infant participants born small for gestational age
Percentage of infant participants born small for gestational age, where birthweight is less than 10th percentile for sex and gestational age assigned at birth, based on Intergrowth 21st Standards
Measured: Birth
Percentage of infant participants with low birth weight
Percentage of infant participants with low birth weight, defined as less than 2500 grams
Measured: Birth
Percentage of infant participants born preterm
Percentage of infant participants born preterm, defined as less than 37 weeks gestation
Measured: Birth
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome. Outcomes include: spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 gestational weeks), small for gestational age (<10th percentile per INTERGROWTH 21st Standards), or neonatal death
Measured: Through 6 weeks postpartum
Percentage of infant participants with a congenital anomaly
Percentage of infant participants with a congenital anomaly based on the Metropolitan Atlanta Congenital Defects Program (MACDP) definition of defect
Measured: Birth
Percentage of infant deaths
Percentage of infant deaths
Measured: Measured from birth through six weeks post-birth
Percentage of adult participants who would recommend CAB LA and RPV LA injections for other people living with HIV during pregnancy
Percentage of adult participants who would recommend CAB LA and RPV LA injections
Measured: Six weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Oct 2026
- Primary completion22 Apr 2028 (estimated)
- Study completion22 Apr 2028 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Rachel Scott, MD, MPH, Study chair, MedStar Washington Hospital Center & MedStar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637942
- Sponsor's protocol ID
- IMPAACT 2050
- Other IDs
- UM1AI068632, UM1AI068616, UM1AI106716
- Acronym
- CREATE
- Status last verified
- Nov 2026
- First submitted
- 27 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States
- ClinicalTrials.gov ID
- NCT07637942
- Acronym / sponsor ID
- CREATE / IMPAACT 2050
- Conditions
- HIV -1 Infection
- Keywords
- HIV, Pregnancy, CAB LA + RPV LA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 22 Apr 2028 (estimated)
- Study completion
- 22 Apr 2028 (estimated)
- First posted
- 10 Jun 2026 (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.
Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.
Detailed description
Up to 40 adult-participants with HIV viral suppression will be enrolled, in pairs with their infants, to achieve 30 evaluable adult-participants overall. The study will include women who initiated CAB LA + RPV LA outside the study, prior to study entry, either pre-conception (including on the day of conception) or post-conception.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAB LA + RPV LA Initiation Pre Conception | Experimental | Drug: Every 4-week long-acting injectable cabotegravir and rilpivirinePregnant women with controlled HIV who were using CAB LA + RPV LA pre-conception, and continue to receive Q4W CAB LA + RPV LA |
| CAB LA + RPV LA Initiation Post Conception | Experimental | Drug: Every 4-week long-acting injectable cabotegravir and rilpivirinePregnant women with controlled HIV who switch from oral SOC and initiate Q4W CAB LA + RPV LA post-conception, and continue to receive CAB LA + RPV LA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide written informed consent for study participation for self and infant
- At screening, age 18 years or older
- Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry
- At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up
- Was diagnosed with HIV prior to the current pregnancy
Key exclusion criteria (8 listed)
- History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)
- Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV; (3) Current contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which may interfere with the interpretation of ISRs; (4) Current use or anticipated need of therapeutic anticoagulation; (5) History of known or suspected bleeding disorder; (6) Current severe hepatic impairment (Class C) as determined by Child-Pugh classification; (7) History of suicidal ideation or attempt within six months of entry; (8) History of unstable or poorly controlled seizure disorder; (9) Current tuberculosis infection; (10) Current cervical intraepithelial neoplasia (CIN) 2 or 3, or malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma
- Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta; (2) Cervical cerclage/cervical incompetence; (3) Abnormal fetal anatomy
- Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome; (2) Intrauterine fetal demise (EGA greater than 20 weeks) without known nonrecurrent etiology; (3) Spontaneous very preterm delivery (less than 32 weeks); (4) Very LBW (less than 1500 g); (5) Cervical or abdominal cerclage due to cervical incompetence
- Receipt of any prohibited medication within seven days prior to entry
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 |
|---|---|---|
| Every 4-week long-acting injectable cabotegravir and rilpivirineLong-acting injectable cabotegravir and rilpivirine, initiated pre-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider. | Drug | CAB LA + RPV LA Initiation Pre Conception |
| Every 4-week long-acting injectable cabotegravir and rilpivirineLong-acting injectable cabotegravir and rilpivirine, initiated post-conception. Participants will receive these drugs as prescribed outside the study by their non-study clinical care provider. | Drug | CAB LA + RPV LA Initiation Post Conception |
Primary outcome
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Time frame: Measured from study entry through six weeks postpartum
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
Time frame: Measured from study entry through six weeks postpartum
Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum
17 secondary outcomes
Percentage of adult participants with HIV RNA less than 50 copies/mL at delivery
Time frame: Delivery
Percentage of adult participants with virologic escape
Time frame: Measured from study entry through six weeks postpartum
Percentage of adult participants with confirmed virologic failure
Time frame: Through 6 weeks postpartum
Number of adult participants with HIV resistance to CAB or RPV who had confirmed virologic failure
Time frame: Through 6 weeks postpartum
Number of infant participants with perinatal transmission
Time frame: Birth and six weeks post-birth
Percentage of adult participants with at least one Grade 3 or higher adverse event
Time frame: Measured from study entry through six weeks postpartum
Percentage of adult participants with at least one serious adverse event
Time frame: Measured from study entry through six weeks postpartum
Percentage of infant participants with at least one serious adverse event
Time frame: Measured from birth through six weeks post-birth
Percentage of adult participants with spontaneous abortion
Time frame: Through 6 weeks postpartum
Percentage of adult participants with fetal demise/stillbirth
Time frame: Through 6 weeks postpartum
Percentage of infant participants born small for gestational age
Time frame: Birth
Percentage of infant participants with low birth weight
Time frame: Birth
Percentage of infant participants born preterm
Time frame: Birth
Percentage of mother-infant pairs with occurrence of any adverse pregnancy outcome
Time frame: Through 6 weeks postpartum
Percentage of infant participants with a congenital anomaly
Time frame: Birth
Percentage of infant deaths
Time frame: Measured from birth through six weeks post-birth
Percentage of adult participants who would recommend CAB LA and RPV LA injections for other people living with HIV during pregnancy
Time frame: Six weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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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.
Rachel Scott, MD, MPH study chair
MedStar Washington Hospital Center & MedStar Health Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Every 4-week long-acting injectable cabotegravir and rilpivirine in people with HIV -1 Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 10 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Levy (2028848480, LLEVY@FHI360.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model (time frame: Measured from study entry through six weeks postpartum). 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 3 Nov 2026.