HIVPhase 1NCT05406583
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
A Phase 1 study testing Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses) and Dolutegravir 5 mg Dispersible Tablets (chronic dose) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in 3 countries.
Trial summary
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1. The primary goal of the study was to propose a dose of DTG that is safe and meets PK targets when administered to infants through the first four weeks of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- What is being tested?
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses) and Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 5 Oct 2022to 22 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for her and permission for her infant's participation in this study.
- Mother has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes per Sample #1 and Sample #2 protocol requirements. Test results may be obtained from medical records or from testing performed during the study screening period:
- For results obtained from medical records, adequate source documentation, including the date of specimen collection, date of testing or date of test result, name of test/assay performed, and test result, must be available in study records prior to study entry. Requirements related to laboratory operations (e.g., CLIA, GCLP, or VQA) and related to regulatory authority (e.g., FDA) approvals do not apply to results obtained from medical records.
- If adequate source documentation is not available, Sample #1 and/or Sample #2 should be collected during the study screening period and tested in the site's designated testing laboratory. If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to CLIA or equivalent (for US sites) or GCLP (for non-US sites) guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing is used, at least one test must be performed in the site's CLIA-certified or equivalent (for US sites) or VQA-certified (for non-US sites) laboratory.
- All study-specific samples tested to determine HIV-1 status must be whole blood, serum, or plasma. HIV testing methods and algorithms must be approved for each site by the IMPAACT Laboratory Center (for NIAID-funded sites) or Westat (for NICHD-funded sites). All test methods should be FDA-approved, if available.
- At entry, infant meets DTG exposure requirements, based on mother's report and confirmed by medical records if available, as follows:
Show all 22Show fewer
- For Cohort 1, Strata 1A and 1C, and Cohort 2, Stratum 2A: Infant born to a mother who did not receive DTG during the two weeks immediately prior to delivery.
- For Cohort 1, Stratum 1B, and Cohort 2, Stratum 2B: Infant born to a mother who received at least one dose of DTG less than or equal to 72 hours prior to delivery.
- Infant was singleton with a gestational age at birth of at least 37 weeks.
- At birth, infant's weight was as follows:
- For Cohort 1, Strata 1A,1B, 1C, and Cohort 2, Strata 2A and 2B: At least 2 kg
- At screening, infant has the following laboratory test results, based on severity grading specified in the protocol section 7.3.3:
- ALT (normal)
- AST (normal or Grade 1)
- Total bilirubin (normal or Grade 1)
- Hemoglobin (normal, Grade 1, or Grade 2)
- White blood cells (normal, Grade 1, or Grade 2)
- Platelets (normal, Grade 1, or Grade 2)
- Creatinine (normal, Grade 1, or Grade 2)
- At entry, infant is less than or equal to five days of life.
- At entry, infant has initiated standard of care ARV prophylaxis (i.e., received at least one dose of ARV regimen prior to entry).
- At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.
Who cannot join
- Known maternal-fetal blood group incompatibility as evidenced by the presence of an unexpected clinically significant maternal red blood cell antibody that is known to cause hemolytic disease of the fetus and newborn.
- Infant or breastfeeding mother is receiving any disallowed medicationlisted in protocol Section 5.8.1.
- At entry, infant with a documented positive HIV nucleic acid test result.
- Infants with prior exchange transfusion or with elevated bilirubin that would require exchange transfusion.
- Mother or infant has any condition that, in the opinion of the site investigator or designee, 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
15 sites in 3 countries.
15 sites in 3 countries
United States8 sites
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, 30322
University of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
Rush University, Cook County Hospital Chicago NICHD CRS
Chicago, Illinois, 60612
Baylor College of Medicine/ Texas Children's Hospital NICHD CRS
Houston, Texas, 77030
USC - Maternal Child Adolescent/Adult Center
Los Angeles, California, 90033-1075
David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, 90095-1752
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-3678
Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, 10457
South Africa4 sites
FAMCRU
Cape Town, 7500
Umlazi
Durban, KwaZulu-Natal, 4013
Soweto
Johannesburg, Gauteng, 1864
Wits RHI Shandukani Research Centre CRS
Johannesburg, Gauteng, 2001
Thailand3 sites
Siriraj Hospital, Mahidol University NICHD CRS
Bangkok, 10700
Chiang Mai University HIV Treatment
Chiang Mai, 50200
Chiangrai Prachanukroh Hospital NICHD CRS
Chiang Rai, 57000
About this study
Official title: A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1. The primary goal of the study was to propose a dose of DTG that is safe and meets PK targets when administered to infants through the first four weeks of life in addition to the infant's standard HIV-1 ARV prophylaxis. The study was expected to enroll a minimum of 36 and up to 108 mother-infant (M-I) pairs from Brazil, South Africa, Thailand, and the United States. Infants were followed through 16 weeks of life. Mothers did not receive study drug and were off study after completion of the Entry visit. A total of 48 M-I pairs were enrolled in the study.
Read the detailed description
This was a Phase I, multi-centered, open-label, non-comparative dose-finding study to evaluate the safety, tolerability, and PK of DTG when added to standard ARV prophylaxis in singleton full-term (≥ 37 weeks gestation at birth) infants born to mothers living with HIV-1, and to propose an appropriate DTG dosing regimen during the first four weeks of life for infants born to mothers living with HIV-1.
The infant and mother were enrolled as a pair, with the mother taken off study after completing the Entry visit and the infant followed through the Week 16 visit (Days 112-140 of life).
Infants were enrolled in two sequential dosing cohorts: Cohort 1 (two single DTG doses) and Cohort 2 (chronic DTG dosing through a Week 4 or 6 visit per local standard of care for ARV prophylaxis). Cohort 1 was intended to generate the PK and safety data that would inform DTG dose selection for Cohort 2.
At study entry in both cohorts, the participants were stratified based on the infant's in utero exposure to maternal DTG using the criteria below:
- DTG-naïve: Infant born to a mother who did not receive DTG during the two weeks immediately prior to delivery.
- DTG-exposed: Infant born to a mother who received at least one dose of DTG less than or equal to 72 hours prior to delivery.
Across the two cohorts and two in utero exposure groups there were five study strata.
Cohort 1: Two single DTG doses approximately seven days apart.
- Cohort 1 Stratum 1A (DTG-naïve): DTG-naïve infants receiving 2 doses of DTG liquid suspension, with 1st dose at 0-5 days of life and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
- Cohort 1 Stratum 1B (DTG-exposed): DTG-exposed infants receiving 2 doses of DTG liquid suspension, with 1st dose at 2-5 days of life and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
- Cohort 1 Stratum 1C (DTG-naïve): DTG-naïve infants receiving 2 doses of DTG dispersible tablets, with 1st dose at 0-5 days of life and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
Cohort 2: Chronic DTG dosing through Week 4 or 6 visit based on the duration of local standard ARV prophylaxis.
- Cohort 2 Stratum 2A (DTG-naïve): DTG-naïve infants receiving DTG 5 mg dispersible tablets every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
- Cohort 2 Stratum 2B (DTG-exposed): DTG-exposed infants receiving DTG 5 mg dispersible tablets every 48 hours from from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
A minimum of 12 and up to 36 M-I pairs (across strata) were planned to be enrolled in Cohort 1 to achieve a target of six evaluable infants in each stratum to provide PK and safety data to determine the starting DTG dose for each stratum in Cohort 2. A minimum of 24 and up to 72 mother-infant pairs (across both strata) were planned to be enrolled in Cohort 2 to achieve a target of 12 evaluable infants in both Strata 2A and 2B receiving the final proposed chronic dose of DTG. Breastfeeding and formula-feeding infants were eligible for both Cohorts 1 and 2. At least eight breastfeeding and eight formula-feeding infants were planned to be enrolled in Cohort 2 across both strata.
Infant PK samples were collected as follows:
Cohort 1:
- Dose #1 (0-5 days of life) intensive PK sampling: prior to observed dose, 1-2 hours (±15 min) post-dose, 4-8 hours (±15 min) post-dose, 11-13 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose, 48-72 hours (±15 min) post-dose.
- Dose #2 [7 days post initial dose (+3 days)] intensive PK sampling: prior to observed dose, 1-2 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose.
Cohort 2:
- First intensive PK sampling [7 days post initial dose (+3 days)]: prior to observed dose, 1-2 hours (±15 min) post-dose, 6-10 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose (collect PK sample prior to administration of next DTG dose if every 24-hour dosing interval used), prior to administration of the next dose (a sample at this time point should only be collected for Cohort 2 infants with DTG dose regimen administered more than every 24 hours, e.g., every 48 or 72 hours).
- Second intensive PK sampling [Week 4 (23-33 days of life)]: prior to observed dose, 1-2 hours (±15 min) post-dose, 6-10 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose (collect PK sample prior to administration of next DTG dose if every 24-hour dosing interval used).
Infant safety evaluations were done at:
- Cohort 1: Entry, 7 days post initial dose, Week 4, Week 6, Week 16
- Cohort 2: Entry, 2 days post initial dose, 7 days post initial dose, Week 4, Week 6, Week 8, Week 12, Week 16.
Infant tolerability evaluations were done at:
- Cohort 1: Dose #1 (0-5 days of life), Dose #2 [7 days post initial dose (+3 days)]
- Cohort 2: Entry, 2 days post initial dose, 7 days post initial dose (+3 days), Week 4, Week 6
Safety data included infant clinical data, laboratory test results and information on any infant deaths. Laboratory test results included evaluations specified in the protocol and results from the infant's clinical care. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Adverse events were defined as the occurrence of at least one grade 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening), or 5 (death) adverse event, during the study follow-up. In addition, grading of axillary measured fever and plasma creatinine grading in this study followed protocol section 7.3.3. The study site's assessment of adverse event attribution to study drug was used. For the final analysis, all infants who received at least one dose of DTG are safety evaluable (same as in the Regulatory Submission Report).
The protocol pharmacologists determined whether PK parameters can be estimated from the specimens collected, and as described in Protocol Section 3, these determinations were used to determine whether participants are PK evaluable.
- Conditions
- HIV
- Being tested
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose), Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life)
- Keywords
- Antiretroviral, Dolutegravir, Newborn, Infant, HIV/AIDS, Perinatal, Pharmacokinetics, Prophylaxis, Prevention, Safety
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life)Drug
Also called DTG
DTG 0.5 mg/kg liquid suspension administered orally once at Entry visit (0-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days).
Mothers do not receive any drug
Dolutegravir 5 mg Dispersible Tablets (single doses)Drug
Also called DTG
DTG 5 mg dispersible tablets administered orally once at Entry visit (0-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days) Mothers do not receive any drug
Dolutegravir 5 mg Dispersible Tablets (chronic dose)Drug
Also called DTG
DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis at each site Mothers do not receive any drug
Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life)Drug
Also called DTG
DTG 0.5 mg/kg liquid suspension administered orally once at Entry visit (2-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days).
| Study group | Role | What they receive |
|---|---|---|
| Infant Cohort 1 Stratum 1A | Experimental | Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) who received two single doses of DTG 0.5 mg/kg liquid suspensions Receives: Drug: Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life) |
| Infant Cohort 1 Stratum 1B | Experimental | Infants with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) who received two single doses of DTG 0.5 mg/kg liquid suspensions Receives: Drug: Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life) |
| Infant Cohort 1 Stratum 1C | Experimental | Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) who received two single doses of DTG 5 mg dispersible tablet Receives: Drug: Dolutegravir 5 mg Dispersible Tablets (single doses) |
| Infant Cohort 2 Stratum 2A | Experimental | Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) who received chronic dosing of DTG 5 mg dispersible tablet Receives: Drug: Dolutegravir 5 mg Dispersible Tablets (chronic dose) |
| Infant Cohort 2 Stratum 2B | Experimental | Infants with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) who received chronic dosing of DTG 5 mg dispersible tablet Receives: Drug: Dolutegravir 5 mg Dispersible Tablets (chronic dose) |
| Maternal Cohort 1 Stratum 1A | No intervention | Mothers of infants in Cohort 1 Stratum 1A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) |
| Maternal Cohort 1 Stratum 1B | No intervention | Mothers of infants in Cohort 1 Stratum 1B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) |
| Maternal Cohort 1 Stratum 1C | No intervention | Mothers of infants in Cohort 1 Stratum 1C with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) |
| Maternal Cohort 2 Stratum 2A | No intervention | Mothers of infants in Cohort 2 Stratum 2A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) |
| Maternal Cohort 2 Stratum 2B | No intervention | Mothers of infants in Cohort 2 Stratum 2B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Infants Classified as Study Drug-related Safety Failures Through 2 Weeks After DTG-Discontinuation.
An infant is classified as a "study drug-related" safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date):
- Grade 3 or 4 Adverse Event (AE) assessed as related to study drug, or
- Death (Grade 5 AE) assessed as related to the study drug, or
- Life-threatening AE assessed as related to study drug, or
- AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Measured: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
Proportion of Infants Classified as Safety Failures Through 2 Weeks After DTG-Discontinuation.
An infant is classified as a safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date):
- Grade 3 or 4 AE, or
- Death (Grade 5 AE)
Measured: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
Proportion of Infants Who Are Not Able to Tolerate the Study Drug.
An infant is considered not able to tolerate the study drug if the infant experiences problems taking the study drug or experiences any AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Measured: Initial study drug dosing through study drug discontinuation, up to 3 weeks for Cohort 1 and up to 8 weeks for Cohort 2
DTG Ctrough for Cohort 1
Cohort 1 Trough concentration (Ctrough) based on intensive PK sampling for DTG. Ctrough is defined as the concentration at the last measurable time point or at the end of dosing interval.
Measured: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose; 7 Days (+3 days) Post Initial Dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dose
DTG AUC0-48 for Cohort 1 at Entry Visit
Cohort 1 area under the concentration-time curve at 48-hour interval (AUC0-48) based on intensive PK sampling for DTG at Entry visit.
Measured: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose
DTG AUC0-24 for Cohort 1 at 7 Days (+3 Days) Post Initial Dose Visit
Cohort 1 area under the concentration-time curve at 24-hour interval (AUC0-24) based on intensive PK sampling for DTG at 7 Days (+3 days) Post Initial Dose Visit.
Measured: 7 days (+3 days) post initial dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dose
DTG Ctrough for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
Cohort 2 Trough concentration (Ctrough) based on intensive PK sampling for DTG. For the five participants with PK sampling performed at the last dose of Q48h dosing (first dose of Q24h dosing, and a 48-hour sample was not collected), Ctrough was estimated using the terminal slope of preceding points.
Based on the protocol-defined visit windows, the 7 days post initial dose visit may occur between 7 and 15 days of life. At this visit, participants may be receiving either Q48h or Q24h dosing, depending on the timing of their first dose day and the day for the 7 days post initial dose visit.
Measured: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)
DTG Ctrough for Cohort 2 at Week 4
Cohort 2 Trough concentration (Ctrough) based on intensive PK sampling for DTG
Measured: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dose
DTG AUC(0-tau) for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
Cohort 2 area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-tau) based on intensive PK sampling for DTG at 7 Days (+3 days) Post Initial Dose Visit.
Based on the protocol-defined visit windows, the 7 days post initial dose visit may occur between 7 and 15 days of life. At this visit, participants may be receiving either Q48h or Q24h dosing, depending on the timing of their first dose day and the day for the 7 days post initial dose visit.
Measured: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)
DTG AUC(0-tau) for Cohort 2 at Week 4 Visit
Cohort 2 area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-tau) based on intensive PK sampling for DTG at Week 4 visit
Measured: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dose
Secondary outcomes (2)
Proportion of Infants Classified as Study Drug-related Safety Failures Through 16 Weeks.
An infant is classified as a "study drug-related" safety failure for the secondary study safety objective if any of the following occurred after the initial study drug dosing through Week 16:
- Grade 3 or 4 AE assessed as related to study drug, or
- Death (Grade 5 AE) assessed as related to the study drug, or
- Life-threatening AE assessed as related to study drug, or
- AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Measured: Initial study drug dosing through Week 16
Proportion of Infants Classified as Safety Failures Through 16 Weeks.
An infant is classified as a safety failure for the secondary study safety objective if any of the following occurred after the initial study drug dosing through Week 16:
- Grade 3 or 4 AE, or
- Death (Grade 5 AE)
Measured: Initial study drug dosing through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start5 Oct 2022
- Primary completion12 Mar 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- ViiV Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Diana Clarke, Pharm.D., Study chair, Boston Medical Center/ Section of Pediatric Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406583
- Sponsor's protocol ID
- IMPAACT 2023
- Other IDs
- 38637
- Status last verified
- May 2026
- First submitted
- 1 Jun 2022
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Publications
Momper JD, Wang J, Bradford S, Mustich I, Johnston B, Whitson K, O'Brien M, Goldberg E, Yin DE, Townley E, Colsh K, DeYampert T, Beijer-Spell C, Wittawatmongkol O, Aziz M, Naidoo M, Ruenglerdpong S, Bekker A, Deville JG, Cruz MLS, Mathiba SR, Buchanan AM, McKenna M, Mehta R, Chandasana H, Acosta EP, Best BM, Mirochnick M, Powis KM, Shapiro DE, Clarke DF; IMPAACT 2023 Study Team. Pharmacokinetics and safety of dolutegravir in term neonates exposed to HIV-1 (IMPAACT 2023): a phase 1, open-label, multicentre study. Lancet HIV. 2026 Oct 21:S2352-3018(26)00226-2. doi: 10.1016/S2352-3018(26)00226-2. Online ahead of print.
PubMed 42906569
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
- ClinicalTrials.gov ID
- NCT05406583
- Acronym / sponsor ID
- IMPAACT 2023
- Conditions
- HIV
- Keywords
- Antiretroviral, Dolutegravir, Newborn, Infant, HIV/AIDS, Perinatal, Pharmacokinetics, Prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- ViiV Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 22 May 2026
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 was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1. The primary goal of the study was to propose a dose of DTG that is safe and meets PK targets when administered to infants through the first four weeks of life in addition to the infant's standard HIV-1 ARV prophylaxis. The study was expected to enroll a minimum of 36 and up to 108 mother-infant (M-I) pairs from Brazil, South Africa, Thailand, and the United States. Infants were followed through 16 weeks of life. Mothers did not receive study drug and were off study after completion of the Entry visit. A total of 48 M-I pairs were enrolled in the study.
Detailed description
This was a Phase I, multi-centered, open-label, non-comparative dose-finding study to evaluate the safety, tolerability, and PK of DTG when added to standard ARV prophylaxis in singleton full-term (≥ 37 weeks gestation at birth) infants born to mothers living with HIV-1, and to propose an appropriate DTG dosing regimen during the first four weeks of life for infants born to mothers living with HIV-1.
The infant and mother were enrolled as a pair, with the mother taken off study after completing the Entry visit and the infant followed through the Week 16 visit (Days 112-140 of life).
Infants were enrolled in two sequential dosing cohorts: Cohort 1 (two single DTG doses) and Cohort 2 (chronic DTG dosing through a Week 4 or 6 visit per local standard of care for ARV prophylaxis). Cohort 1 was intended to generate the PK and safety data that would inform DTG dose selection for Cohort 2.
At study entry in both cohorts, the participants were stratified based on the infant's in utero exposure to maternal DTG using the criteria below:
- DTG-naïve: Infant born to a mother who did not receive DTG during the two weeks immediately prior to delivery.
- DTG-exposed: Infant born to a mother who received at least one dose of DTG less than or equal to 72 hours prior to delivery.
Across the two cohorts and two in utero exposure groups there were five study strata.
Cohort 1: Two single DTG doses approximately seven days apart.
- Cohort 1 Stratum 1A (DTG-naïve): DTG-naïve infants receiving 2 doses of DTG liquid suspension, with 1st dose at 0-5 days of life and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
- Cohort 1 Stratum 1B (DTG-exposed): DTG-exposed infants receiving 2 doses of DTG liquid suspension, with 1st dose at 2-5 days of life and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
- Cohort 1 Stratum 1C (DTG-naïve): DTG-naïve infants receiving 2 doses of DTG dispersible tablets, with 1st dose at 0-5 days of life and 2nd dose at the 7 Days (+3 days) Post Initial Dose visit.
Cohort 2: Chronic DTG dosing through Week 4 or 6 visit based on the duration of local standard ARV prophylaxis.
- Cohort 2 Stratum 2A (DTG-naïve): DTG-naïve infants receiving DTG 5 mg dispersible tablets every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
- Cohort 2 Stratum 2B (DTG-exposed): DTG-exposed infants receiving DTG 5 mg dispersible tablets every 48 hours from from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis.
A minimum of 12 and up to 36 M-I pairs (across strata) were planned to be enrolled in Cohort 1 to achieve a target of six evaluable infants in each stratum to provide PK and safety data to determine the starting DTG dose for each stratum in Cohort 2. A minimum of 24 and up to 72 mother-infant pairs (across both strata) were planned to be enrolled in Cohort 2 to achieve a target of 12 evaluable infants in both Strata 2A and 2B receiving the final proposed chronic dose of DTG. Breastfeeding and formula-feeding infants were eligible for both Cohorts 1 and 2. At least eight breastfeeding and eight formula-feeding infants were planned to be enrolled in Cohort 2 across both strata.
Infant PK samples were collected as follows:
Cohort 1:
- Dose #1 (0-5 days of life) intensive PK sampling: prior to observed dose, 1-2 hours (±15 min) post-dose, 4-8 hours (±15 min) post-dose, 11-13 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose, 48-72 hours (±15 min) post-dose.
- Dose #2 [7 days post initial dose (+3 days)] intensive PK sampling: prior to observed dose, 1-2 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose.
Cohort 2:
- First intensive PK sampling [7 days post initial dose (+3 days)]: prior to observed dose, 1-2 hours (±15 min) post-dose, 6-10 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose (collect PK sample prior to administration of next DTG dose if every 24-hour dosing interval used), prior to administration of the next dose (a sample at this time point should only be collected for Cohort 2 infants with DTG dose regimen administered more than every 24 hours, e.g., every 48 or 72 hours).
- Second intensive PK sampling [Week 4 (23-33 days of life)]: prior to observed dose, 1-2 hours (±15 min) post-dose, 6-10 hours (±15 min) post-dose, 22-26 hours (±15 min) post-dose (collect PK sample prior to administration of next DTG dose if every 24-hour dosing interval used).
Infant safety evaluations were done at:
- Cohort 1: Entry, 7 days post initial dose, Week 4, Week 6, Week 16
- Cohort 2: Entry, 2 days post initial dose, 7 days post initial dose, Week 4, Week 6, Week 8, Week 12, Week 16.
Infant tolerability evaluations were done at:
- Cohort 1: Dose #1 (0-5 days of life), Dose #2 [7 days post initial dose (+3 days)]
- Cohort 2: Entry, 2 days post initial dose, 7 days post initial dose (+3 days), Week 4, Week 6
Safety data included infant clinical data, laboratory test results and information on any infant deaths. Laboratory test results included evaluations specified in the protocol and results from the infant's clinical care. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Adverse events were defined as the occurrence of at least one grade 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening), or 5 (death) adverse event, during the study follow-up. In addition, grading of axillary measured fever and plasma creatinine grading in this study followed protocol section 7.3.3. The study site's assessment of adverse event attribution to study drug was used. For the final analysis, all infants who received at least one dose of DTG are safety evaluable (same as in the Regulatory Submission Report).
The protocol pharmacologists determined whether PK parameters can be estimated from the specimens collected, and as described in Protocol Section 3, these determinations were used to determine whether participants are PK evaluable.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Infant Cohort 1 Stratum 1A | Experimental | Drug: Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life)Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) who received two single doses of DTG 0.5 mg/kg liquid suspensions |
| Infant Cohort 1 Stratum 1B | Experimental | Drug: Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life)Infants with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) who received two single doses of DTG 0.5 mg/kg liquid suspensions |
| Infant Cohort 1 Stratum 1C | Experimental | Drug: Dolutegravir 5 mg Dispersible Tablets (single doses)Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) who received two single doses of DTG 5 mg dispersible tablet |
| Infant Cohort 2 Stratum 2A | Experimental | Drug: Dolutegravir 5 mg Dispersible Tablets (chronic dose)Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) who received chronic dosing of DTG 5 mg dispersible tablet |
| Infant Cohort 2 Stratum 2B | Experimental | Drug: Dolutegravir 5 mg Dispersible Tablets (chronic dose)Infants with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) who received chronic dosing of DTG 5 mg dispersible tablet |
| Maternal Cohort 1 Stratum 1A | No intervention | –Mothers of infants in Cohort 1 Stratum 1A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) |
| Maternal Cohort 1 Stratum 1B | No intervention | –Mothers of infants in Cohort 1 Stratum 1B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) |
| Maternal Cohort 1 Stratum 1C | No intervention | –Mothers of infants in Cohort 1 Stratum 1C with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) |
| Maternal Cohort 2 Stratum 2A | No intervention | –Mothers of infants in Cohort 2 Stratum 2A with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) |
| Maternal Cohort 2 Stratum 2B | No intervention | –Mothers of infants in Cohort 2 Stratum 2B with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for her and permission for her infant's participation in this study.
- Mother has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes per Sample #1 and Sample #2 protocol requirements. Test results may be obtained from medical records or from testing performed during the study screening period:
- At entry, infant meets DTG exposure requirements, based on mother's report and confirmed by medical records if available, as follows:
- Infant was singleton with a gestational age at birth of at least 37 weeks.
- At birth, infant's weight was as follows:
Key exclusion criteria (5 listed)
- Known maternal-fetal blood group incompatibility as evidenced by the presence of an unexpected clinically significant maternal red blood cell antibody that is known to cause hemolytic disease of the fetus and newborn.
- Infant or breastfeeding mother is receiving any disallowed medicationlisted in protocol Section 5.8.1.
- At entry, infant with a documented positive HIV nucleic acid test result.
- Infants with prior exchange transfusion or with elevated bilirubin that would require exchange transfusion.
- Mother or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
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 |
|---|---|---|
| Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life)Also: DTGDTG 0.5 mg/kg liquid suspension administered orally once at Entry visit (0-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days). Mothers do not receive any drug | Drug | Infant Cohort 1 Stratum 1A |
| Dolutegravir 5 mg Dispersible Tablets (single doses)Also: DTGDTG 5 mg dispersible tablets administered orally once at Entry visit (0-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days) Mothers do not receive any drug | Drug | Infant Cohort 1 Stratum 1C |
| Dolutegravir 5 mg Dispersible Tablets (chronic dose)Also: DTGDTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis at each site Mothers do not receive any drug | Drug | Infant Cohort 2 Stratum 2A, Infant Cohort 2 Stratum 2B |
| Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life)Also: DTGDTG 0.5 mg/kg liquid suspension administered orally once at Entry visit (2-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days). | Drug | Infant Cohort 1 Stratum 1B |
Primary outcome
Proportion of Infants Classified as Study Drug-related Safety Failures Through 2 Weeks After DTG-Discontinuation.
Time frame: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
An infant is classified as a "study drug-related" safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date): * Grade 3 or 4 Adverse Event (AE) assessed as related to study drug, or * Death (Grade 5 AE) assessed as related to the study drug, or * Life-threatening AE assessed as related to study drug, or * AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
Proportion of Infants Classified as Safety Failures Through 2 Weeks After DTG-Discontinuation.
Time frame: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2
An infant is classified as a safety failure for the primary safety study objective if any of the following occurred after the initial study drug dosing through two weeks after permanent discontinuation of the study drug (i.e., two weeks after off treatment date): * Grade 3 or 4 AE, or * Death (Grade 5 AE)
Proportion of Infants Who Are Not Able to Tolerate the Study Drug.
Time frame: Initial study drug dosing through study drug discontinuation, up to 3 weeks for Cohort 1 and up to 8 weeks for Cohort 2
An infant is considered not able to tolerate the study drug if the infant experiences problems taking the study drug or experiences any AE assessed as related to study drug that leads to premature permanent discontinuation of the study drug.
DTG Ctrough for Cohort 1
Time frame: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose; 7 Days (+3 days) Post Initial Dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dose
Cohort 1 Trough concentration (Ctrough) based on intensive PK sampling for DTG. Ctrough is defined as the concentration at the last measurable time point or at the end of dosing interval.
DTG AUC0-48 for Cohort 1 at Entry Visit
Time frame: Entry visit intensive PK sampling (0-5 days of life): pre-dose, and 1-2, 4-8, 11-13, 22-26 and 48-72 hours post-dose
Cohort 1 area under the concentration-time curve at 48-hour interval (AUC0-48) based on intensive PK sampling for DTG at Entry visit.
DTG AUC0-24 for Cohort 1 at 7 Days (+3 Days) Post Initial Dose Visit
Time frame: 7 days (+3 days) post initial dose intensive PK sampling: pre-dose, and 1-2, 22-26 hours post-dose
Cohort 1 area under the concentration-time curve at 24-hour interval (AUC0-24) based on intensive PK sampling for DTG at 7 Days (+3 days) Post Initial Dose Visit.
DTG Ctrough for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
Time frame: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)
Cohort 2 Trough concentration (Ctrough) based on intensive PK sampling for DTG. For the five participants with PK sampling performed at the last dose of Q48h dosing (first dose of Q24h dosing, and a 48-hour sample was not collected), Ctrough was estimated using the terminal slope of preceding points. Based on the protocol-defined visit windows, the 7 days post initial dose visit may occur between 7 and 15 days of life. At this visit, participants may be receiving either Q48h or Q24h dosing, depending on the timing of their first dose day and the day for the 7 days post initial dose visit.
DTG Ctrough for Cohort 2 at Week 4
Time frame: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dose
Cohort 2 Trough concentration (Ctrough) based on intensive PK sampling for DTG
DTG AUC(0-tau) for Cohort 2 at 7 Days (+3 Days) Post Initial Dose Visit
Time frame: 7 days (+3 days) post initial dose PK sampling: pre-dose, and 1-2, 6-10, 22-26 hours post-dose, and prior to the next dose (for infants continuing to receive DTG every 48 hours)
Cohort 2 area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-tau) based on intensive PK sampling for DTG at 7 Days (+3 days) Post Initial Dose Visit. Based on the protocol-defined visit windows, the 7 days post initial dose visit may occur between 7 and 15 days of life. At this visit, participants may be receiving either Q48h or Q24h dosing, depending on the timing of their first dose day and the day for the 7 days post initial dose visit.
DTG AUC(0-tau) for Cohort 2 at Week 4 Visit
Time frame: Week 4 intensive PK sampling (22-33 days of life): pre-dose, and 1-2, 6-10, 22-26 hours post-dose
Cohort 2 area under the concentration-time curve from time zero to the end of the dosing interval (AUC0-tau) based on intensive PK sampling for DTG at Week 4 visit
2 secondary outcomes
Proportion of Infants Classified as Study Drug-related Safety Failures Through 16 Weeks.
Time frame: Initial study drug dosing through Week 16
Proportion of Infants Classified as Safety Failures Through 16 Weeks.
Time frame: Initial study drug dosing through Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42906569Momper JD, Wang J, Bradford S, Mustich I, Johnston B, Whitson K, O'Brien M, Goldberg E, Yin DE, Townley E, Colsh K, DeYampert T, Beijer-Spell C, Wittawatmongkol O, Aziz M, Naidoo M, Ruenglerdpong S, Bekker A, Deville JG, Cruz MLS, Mathiba SR, Buchanan AM, McKenna M, Mehta R, Chandasana H, Acosta EP, Best BM, Mirochnick M, Powis KM, Shapiro DE, Clarke DF; IMPAACT 2023 Study Team. Pharmacokinetics and safety of dolutegravir in term neonates exposed to HIV-1 (IMPAACT 2023): a phase 1, open-label, multicentre study. Lancet HIV. 2026 Oct 21:S2352-3018(26)00226-2. doi: 10.1016/S2352-3018(26)00226-2. Online ahead of print.
- The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, July 2017Link provided by the sponsor.
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
Diana Clarke, Pharm.D. study chair
Boston Medical Center/ Section of Pediatric Infectious Diseases
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses) and Dolutegravir 5 mg Dispersible Tablets (chronic dose) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 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 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, South Africa, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). 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?
Proportion of Infants Classified as Study Drug-related Safety Failures Through 2 Weeks After DTG-Discontinuation. (time frame: Initial study drug dosing through 2 weeks after off treatment date (after treatment discontinuation), up to 5 weeks for Cohort 1 and up to 8 weeks for Cohort 2). The study lists 10 primary outcomes in all. 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 NCT05406583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.